Effects of a resistance training program and subsequent detraining on muscle strength and muscle power in multiple sclerosis patients (2014), PragMS

Here are the PRECIS-2 scores and explanations for the trial based on the full text in “1773.pdf”:

Eligibility criteria

Quotes:

• “Patient inclusion criteria included a confirmed disease diagnosis by a neurologist, according to Mc-Donald criteria (McDonald, 2001); ability to walk (with or without aid) at least 20 m without rest; absence of other diseases that might have affected muscle function.”

• “None of the patients had previous experience with resistance training.”

Explanation: The inclusion criteria seem fairly broad - patients only need to be diagnosed by a neurologist and able to walk 20m without rest. The only notable exclusion is prior resistance training experience, which makes sense in assessing the effect of a resistance training intervention. Overall, the criteria seem fairly pragmatic.

Score: [4]

Recruitment

Quotes:

• “After a group meeting where the details of the investigation were described to the patients, including possible risks and discomfort associated to the intervention, a formal invitation to take part in the study was offered.”

• “All training sessions took place in MS rehabilitation centers and the patients were continuously supervised by physical therapists.”

Explanation: Patients were recruited through MS rehabilitation centers where they were already receiving care. No additional recruitment efforts beyond the group meeting seem to have been made. Recruiting through usual care settings is a pragmatic approach.

Score: [4]

Setting

Quotes:

• “All participants were recruited among six MS rehabilitation centers within the region of Castilla y León (Spain).”

• “All training sessions took place in MS rehabilitation centers and the patients were continuously supervised by physical therapists.”

Explanation: Conducting the trial in the same rehabilitation centers where patients were receiving usual care is a pragmatic choice of setting. Multiple centers were used as well.

Score: [5]

Organization

Quotes:

• “Subjects performed 3 sets of 8–12 reps with a load that was progressively increased from 35 to 70% of MVIC through the training period (Table 2). Recovery time between sets was 3 minutes.”

• “All training sessions took place in MS rehabilitation centers and the patients were continuously supervised by physical therapists.”

Explanation: The intervention was delivered by physical therapists during usual rehabilitation sessions, without requiring additional expertise, training, or resources. This matches usual care and is pragmatic.

Score: [5]

Flexibility: Delivery

Quotes:

• “Subjects were requested to push with maximal effort during the concentric phase of the movement (90–180°) and to lower the load (eccentric action; 180–90°) in a controlled manner.”

• “Table 2 shows the progressive loading scheme used during the resistance training program.”

Explanation: The resistance training protocol is clearly specified, including number of sets/reps, load, and concentric/eccentric timing. This reduces flexibility in delivery and is more explanatory.

Score: [2]

Flexibility: Adherence

Quotes: None relevant

Explanation: There is no mention of any measures to enforce or monitor adherence by patients. This suggests a pragmatic approach.

Score: [5]

Follow-up

Quotes:

• “Testing was performed on three different occasions: before (week 0) and after (week 12) the training program, and after the detraining period (week 24).”

Explanation: Follow-up is limited to testing at baseline, after training, and after detraining. This matches what would occur in usual care and is pragmatic.

Score: [5]

Primary Outcome

Quotes:

• “Dependent variables included maximal voluntary isometric contraction (MVIC), maximal torque, average power and muscle endurance.”

Explanation: The primary outcomes of strength, power, and endurance are clinically meaningful to patients. This is pragmatic.

Score: [5]

Primary Analysis

Quotes:

• “Data were analyzed using SPSS® 17.0 (SPSS Inc., USA).”

• “To assess any training or detraining effect, as well as any difference between groups, MVIC, torque, average power and muscle endurance raw values were examined using two-way ANOVA with repeated measurements for group and time.”

Explanation: The analysis approach is not explicitly described but seems to follow intention-to-treat principles by including all participants and using repeated measures ANOVA. This is pragmatic.

Score: [4]

Long-term effect of ACTH treatment of relapse in multiple sclerosis (1990), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in the publication “1770.pdf”:

Domain 1 - Eligibility criteria

Quotes:

“Only patients with a clinical or laboratory supported definite diagnosis of MS according to the Poser criteria were included.”

“At entry the exacerbation had been lasting less than 8 weeks and no spontaneous recovery had occurred.”

“Patients with contraindications to bed rest or ACTH-treatment, such as hypersensitivity to ACTH, acute infections, cardial insufficiency, psychosis, pregnancy, Cushing syndrome or peptic ulcer, were excluded.”

Explanation: The trial had strict inclusion criteria requiring a definite diagnosis of MS and being in an acute exacerbation phase. It also excluded patients with various comorbidities and contraindications. This makes the sample less representative of real-world MS patients.

Score: [2]

Domain 2 - Recruitment path

Quotes: No relevant quotes. The paper does not describe the recruitment path.

Explanation: Unable to assess due to lack of information.

Score: [NA]

Domain 3 - Setting

Quotes:

“Three neurological departments in the Netherlands (University Hospital Groningen, Streekziekenhuis Almelo, Diaconessenhuis Meppel) participated in this study.”

Explanation: The trial was conducted across multiple centers and hospitals, suggesting a pragmatic approach.

Score: [4]

Domain 4 - Organization

Quotes: No relevant quotes. The paper does not describe the organization.

Explanation: Unable to assess due to lack of information.

Score: [NA]

Domain 5 - Flexibility (delivery)

Quotes: No relevant quotes. The paper does not describe flexibility of delivery.

Explanation: Unable to assess due to lack of information.

Score: [NA]

Domain 6 - Flexibility (adherence)

Quotes: No relevant quotes. The paper does not describe flexibility of adherence.

Explanation: Unable to assess due to lack of information.

Score: [NA]

Domain 7 - Follow-up

Quotes:

“Follow-up was performed in the 6th and 12th week of treatment and 6, 9, and 12 months after the start of treatment.”

“Assessment included: EDSS, FS, AI, ISS, in the 6th and 12th week an overall impression by both the patient and the neurologist in a 7-point scale (from much worse via unchanged to much better), and on a 3-point scale (worse, unchanged, better) in the 6th, 9th and 12th month.”

Explanation: Participants were followed closely with multiple assessments over 12 months. This is more frequent than usual care.

Score: [2]

Domain 8 - Primary outcome

Quotes:

“In some Kurtzke Functional Systems, the Ambulation Index and the Kurtzke Incapacity Scale a transient greater improvement in the ACTH-treated patients was observed.”

Explanation: The primary outcomes of functional systems, ambulation, and disability scales are clinically relevant but may require specialized training to assess.

Score: [3]

Domain 9 - Primary analysis

Quotes: No relevant quotes. The paper does not describe the primary analysis.

Explanation: Unable to assess due to lack of information.

Score: [NA]

Education for people with progressive neurological conditions can have negative effects: evidence from a randomized controlled trial (2004), PragMS

Here are the PRECIS-2 domain scores and explanations for the trial described in “695.pdf”:

1. Eligibility criteria

Relevant quotes:

• “Participants eligible for inclusion were adults aged over 15 years with one of the following possible recorded diagnoses: MS, PD and other causes of progressive parkinsonism, motor neurone disease, Huntington’s disease and other degenerative disorders affecting the central nervous system, muscles or peripheral nerves.”

• “In order to preserve a focus on primarily physical disabilities, dementing disorders such as Alzheimer’s disease were not included.”

• “Participants whose clinical features appeared incompatible with the recorded diagnosis were excluded, as were those with neurological complications of primarily non-neurological conditions such as diabetes mellitus, or additional causes of severe disability.”

The eligibility criteria are reasonably broad, including adults over 15 years old with a range of progressive neurological conditions affecting physical function. However, some common exclusions are made, such as for dementing disorders and diabetes complications, that may limit generalizability. Overall, the criteria seem moderately pragmatic.

Score: [3]

2. Recruitment

Relevant quotes:

• “To avoid ascertainment bias towards people already receiving specific health or social services, we used GP information as the sole method for identifying potential participants.”

Participants were identified solely through GP records and referrals, avoiding additional recruitment efforts that could bias the sample. This routine recruitment approach matches how patients would present in usual care.

Score: [5]

3. Setting

Relevant quotes:

• “The study took place between August 1997 and March 2000 and was approved by the research ethics committee of Queen’s Medical Centre (Nottingham, UK).”

• “From July 1998 we approached the 177 GPs based within the City of Nottingham boundaries (population 282000).”

• “Participants’ homes in the City of Nottingham.”

The trial was conducted in participants’ homes in a specific city in the UK. While a single city may limit generalizability, conducting the trial in patients’ actual homes matches the real-world setting.

Score: [4]

4. Organization

Relevant quotes:

• “In the EG, baseline data were reviewed by an expert panel which advised on actions most likely to promote each individual’s physical, social and psychological well-being.”

• “An occupational therapist (OT) then visited EG participants to provide education and information and to discuss a personalized 12-month health action plan.”

The intervention involves an expert panel review and home visits from an OT to provide personalized education. This likely requires more resources and coordination than usual care.

Score: [2]

5. Flexibility (delivery)

Relevant quotes:

• “An occupational therapist (OT) then visited EG participants to provide education and information and to discuss a personalized 12-month health action plan.”

• “Approximately two weeks later, EG participants received a single follow-through phone call from the research OT to confirm and reinforce the educational content of the visit, after which EG patients had no subsequent contact with the OT”

The education delivery seems reasonably flexible, involving a personalized discussion and plan between the OT and participant. Only 1 follow-up call was made to reinforce the education.

Score: [4]

6. Flexibility (adherence)

Relevant quotes:

No discussion of measures to enforce adherence.

The trial does not appear to monitor or enforce adherence to the education intervention. This matches the flexibility seen in usual practice.

Score: [5]

7. Follow-up

Relevant quotes:

• “Information on adverse events was collected by phone at two-monthly intervals between baseline and 12-month assessments, when a general enquiry was made without specific reference to falls or sores.”

• “To inform the expert panel, an assessor carried out a broad-ranging baseline interview, which included the Braden scale for risk of skin sores,14 risk factors for falling,l and self-reported service utilization.”

Follow-up intensity seems moderately pragmatic - participants were contacted every 2 months by phone without extensive data collection. However, more detailed baseline and 12 month in-person assessments were performed.

Score: [3]

8. Primary outcome

Relevant quotes:

• “Primary outcome measures were reports of one or more falls or skin sores. At interview, participants were asked ‘In the past 12 months, have you fallen? Have you had a skin sore?’”

The primary outcomes of falls and skin sores are directly relevant adverse events for patients with neurological conditions.

Score: [5]

9. Primary analysis

Relevant quotes:

No details provided on primary analysis methods.

The paper does not provide enough information about the primary analysis methods.

Score: [NA]

Long-term treatment of multiple sclerosis with corticotrophin (1967), PragMS

Here are the PRECIS-2 scores for the clinical trial described in the attached paper “1769.pdf”:

Eligibility criteria

Quotes:

“Patients with multiple sclerosis were randomly selected into treated and control groups; only patients who could walk with or without walking aids were admitted to the trial, and these cases were initially assessed and scored during an inactive phase of the disease.”

“Patients with diabetes mellitus or hypertension or who gave a history of psychiatric illness or peptic ulcer were not admitted to the treated group.”

Score: [3]

The eligibility criteria are moderately pragmatic - patients had to have a diagnosis of MS and be ambulatory, which matches the target population, but other exclusions like diabetes, hypertension, and psychiatric illness make it less pragmatic.

Recruitment

Quotes:

“This controlled study was started in 1963 in three cities-Belfast, Leeds, and Manchester.”

“A separate trial was carried out in the three centres using the same treatment and scoring methods. Patients with multiple sclerosis were randomly selected into treated and control groups;”

Score: [4]

Patients were recruited from multiple centers, suggesting a pragmatic recruitment approach. However, no details are provided on how exactly patients were recruited.

Setting

Quotes:

“This controlled study was started in 1963 in three cities-Belfast, Leeds, and Manchester.”

Score: [4]

The trial was conducted across three cities, suggesting a reasonably pragmatic setting.

Organization

Quotes:

“The treated group were given corticotrophin (’ Acthar ’ gel) in a dosage which varied between 15 and 25 units daily, potassium chloride orally, and a low-salt diet.”

Score: [5]

The intervention appears to be delivered as part of routine care without substantial additional resources, suggesting a very pragmatic approach.

Flexibility: Delivery

Quotes:

“The dose of corticotrophin was adjusted to produce just enough” mooning ” of the face to be appreciated by the physician in charge of the trial and the dose was not increased during a relapse.”

Score: [2]

The corticotrophin dosage was standardized based on a specific physician assessment (“mooning” of the face), suggesting an explanatory approach.

Flexibility: Adherence

Score: [NA]

No relevant information provided in the text.

Follow-up

Quotes:

“All cases were seen at three-monthly intervals and scored on the Kurtzke (1961) scale; relapses lasting longer than twenty-four hours were also scored by a system in the three centres.”

Score: [3]

Follow-up every 3 months is more frequent than usual care but not excessively burdensome.

Primary outcome

Quotes:

“There is no evidence to suggest that the treated group do better than the controls, either from the point of view of deterioration or reduction in number or severity of relapses.”

Score: [4]

Deterioration and relapse rate/severity seem like pragmatic and clinically meaningful outcomes.

Primary analysis

Quotes:

No relevant information provided in the text.

Score: [NA]

No details provided on the primary analysis.

Evaluation of the effectiveness of professionally guided self-care for people with multiple sclerosis living in the community: a randomized controlled trial (2002), PragMS

Here are the PRECIS-2 domain scores and justifications for the trial described in “685.pdf”:

Eligibility criteria

Quotes:

• “The only selection criterion was that the diagnosis of MS was confirmed by the general practitioner.”

• “There were no exclusion criteria.”

Reasoning: The trial had very broad eligibility criteria, including anyone with a confirmed diagnosis of MS. There were no exclusions based on age, comorbidities, disease severity, ability to adhere to treatment, or any other factors. This reflects a very pragmatic approach, allowing the results to be widely generalizable.

Score: [5]

Recruitment

Quotes:

• “Participants were volunteers with MS who were recruited through voluntary organizations, were community based and lived in West London and in counties contiguous with Greater London.”

Reasoning: Participants were recruited through MS voluntary organizations rather than clinic visits or medical records. This requires some extra effort compared to recruiting during routine care. However, it seems reasonably feasible that this recruitment approach could occur in usual care.

Score: [4]

Setting

Quote:

• “It was a community-based research study, which was approved by the appropriate local research ethics committees, and was conducted at the Centre for Research in Rehabilitation at Brunel University’s Osterley Campus in West London from June 1996 until February 1999.”

Reasoning: The setting was a university research center rather than a community clinic or other real-world care setting. This reduces the pragmatism of the trial.

Score: [2]

Organization

Quotes:

• “The intervention comprised discussion of self-care based on client priorities, using an information booklet about self-care.”

• “Sessions were conducted either at participants’ homes or in local therapy centres.”

• “The discussions lasted between 1 and 2 hours and were conducted on two occasions, over a one month period.”

Reasoning: The intervention required trained staff to deliver it, which is more resources than usual care. However, it was reasonably brief and delivered in homes/community centers. Overall, it requires some additional resources compared to usual care.

Score: [3]

Flexibility: Delivery

Quotes:

• “As findings from the Delphi study highlighted the need for flexibility and responsiveness to individuals the format of the discussion focused on individuals’ interests and concerns rather than on covering all the information contained in the booklet.”

• “Individuals were assigned to group or one to one sessions by the health professional in consultation with each person, and based on their needs and wishes.”

Reasoning: The delivery allowed flexibility in format based on individual needs and interests. There was no strict protocol. This matches usual care.

Score: [5]

Flexibility: Adherence

Quotes: None relevant

Reasoning: Adherence does not seem applicable for this informational intervention. There is no medication or regimen for patients to adhere to.

Score: [NA]

Follow-up

Quotes:

• “Follow-up assessments were conducted six months after baseline.”

• “The blind code was broken after the final follow-up assessments had occurred.”

Reasoning: Participants were followed up at 6 months, with no other contacts in between. This matches reasonably well with follow-up in usual long-term MS care.

Score: [4]

Primary outcome

Quotes:

• “Total scores on a postal version of the Barthel Index, a scale measuring mobility, the SF-36, and one measure developed for the study; the Standard Day Dependency Record (SDDR), were the main outcome measures.”

Reasoning: The outcomes measured mobility, quality of life, and independence in daily activities. These are highly patient-centered and relevant for MS.

Score: [5]

Primary analysis

Quote:

• “Missing values on scales were replaced with group means for each outcome measure. It was not possible to perform an ‘intention to treat’ analysis as those individuals who declined the intervention also withdrew from follow-up and therefore did not complete any follow-up assessments.”

Reasoning: An intention-to-treat analysis was not done since some patients withdrew after declining intervention. However, missing data was accounted for reasonably. This seems moderately pragmatic.

Score: [3]

Evaluation of a home-based physiotherapy programme for those with moderate to severe multiple sclerosis: a randomized controlled pilot study (2011), PragMS

Here are the PRECIS-2 scores for the trial described in the attached paper “684.pdf”:

Eligibility criteria:

Relevant quotes:

• “Subjects had a definite diagnosis of primary or secondary progressive MS, and an EDSS of between 6.5 (constant bilateral assistance required to walk about 20 metres without resting) to 8 (essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed much of the day, retains many self-care functions and generally has effective use of arms).”

• “People with MS who were medically stable were selected where cognitive function was adequate, as assessed by a Mini Mental State Examination score of 23 or over and had at least three identifiable physiotherapy goals were included.”

• “Potential subjects were excluded if they had rapidly progressing disease, were already involved in a physiotherapy programme, had additional neurological conditions or other medical conditions which would preclude them taking part in the study.”

The eligibility criteria target patients with moderate to severe MS who would be candidates for physiotherapy in usual care. The exclusion criteria remove patients with rapidly progressing disease who would not be suitable. The additional requirement of at least 3 physiotherapy goals ensures selected patients will benefit from the intervention. Overall, the criteria seem very similar to usual care.

Score: [4]

Recruitment:

Relevant quotes:

• “People moderately to severely affected by MS were recruited from the MS Service, NHS Ayrshire and Arran.”

Patients were recruited from an MS service, which is likely the normal source for this population in usual care. No additional recruitment methods were mentioned.

Score: [4]

Setting:

Relevant quotes:

• “Subjects assigned to Group 1 received physiotherapy, twice weekly for eight weeks, by an experienced domiciliary physiotherapist within their home.”

The setting was patients’ own homes, which matches usual care for moderate to severe MS patients.

Score: [5]

Organization:

Relevant quotes:

• “Each session lasted up to 60 minutes, and a task-specific programme included upper and lower limb strengthening using theraband, mobile pedals, and weights. Repetition of tasks such as sit to stand, gait, balance (using gym balls and sit fits) and stretching activities were used depending on the subjects previously identified goals.”

The intervention was delivered by physiotherapists using resources that would be standard in usual care. No additional training or expertise was mentioned.

Score: [5]

Flexibility (delivery):

Relevant quotes:

• “Each subject therefore received core treatments aimed to maximize strength, flexibility and function.”

A tailored program was designed for each patient based on goals. This matches the flexibility expected in usual physiotherapy care.

Score: [5]

Flexibility (adherence):

No discussion of measures to enforce adherence.

Score: [5]

Follow-up:

Relevant quotes:

• “Subjects in both groups were assessed at the beginning and at the end of the eight-week intervention period (i.e. either physiotherapy or control) and then again eight weeks later.”

• “To improve the reliability of the data, all assessments were undertaken at the Douglas Grant Rehabilitation Centre, Irvine, and the assessor remained blind to the subjects’ treatment group allocation.”

Follow-up matches the intervention period with an additional assessment 8 weeks later. Assessments were done at a center rather than home. Frequency is reasonable but location differs from purely usual care.

Score: [4]

Primary outcome:

Relevant quotes:

• “The MS impact scale (MSIS 29), which is a measure of the physical and psychological impact of MS, was the primary outcome measure for the study.”

The MSIS measures outcomes directly relevant to patients.

Score: [5]

Primary analysis:

Relevant quote:

• “Where there were problems with missing data due to dropouts/non-completion, the simple repeated measures ANOVA was replaced with a general linear model where missing data are estimated within the model.”

An intention-to-treat approach was used with statistical methods to account for missing data.

Score: [5]

Home based management in multiple sclerosis: results of a randomised controlled trial (2002), PragMS

Here are the PRECIS-2 scores for the clinical trial described in the attached paper “688.pdf”:

Eligibility criteria

Quotes:

“To be eligible, all patients screened for study participation had to be affected by clinically definite multiple sclerosis and live in the Rome service area.”

“Eligible patients were assessed for suitability by the coordinator of the home based care team (LP).”

Reasoning: The eligibility criteria require patients to have clinically definite multiple sclerosis, which is reasonable for this trial. Patients also had to live in the Rome service area, which may limit generalizability somewhat but is likely similar to eligibility criteria in usual care. The coordinator further assessed patients for suitability, which introduces some selectivity beyond typical eligibility. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Quotes:

“Patients were recruited from the multiple sclerosis centre of the neurological department of La Sapienza University, or from other institutional centres for multiple sclerosis in Rome.”

Reasoning: Patients were recruited through multiple sclerosis clinics, which is a pragmatic approach similar to how patients would present for treatment in usual care. No additional recruitment efforts beyond standard clinic visits are mentioned.

Score: [5]

Setting

Quotes:

“The study was conducted in Rome”

“Patients were recruited from the multiple sclerosis centre of the neurological department of La Sapienza University, or from other institutional centres for multiple sclerosis in Rome.”

Reasoning: The study was conducted at multiple sclerosis clinics in Rome. This matches the setting where patients would receive care in usual practice.

Score: [5]

Organisation

Quotes:

“The home based care multidisciplinary team included two neurologists, a urologist, a rehabilitation physician, a psychologist, a physical therapist, a nurse, a social worker, and a coordinator.”

“The multidisciplinary team collaborated with the patient, physician, and caregiver in designing individualised clinical care and in coordinating home services as appropriate for the individual patient.”

“The type of care was more than is normally available in the community through National Health Service care.”

Reasoning: The home-based intervention used a specialized, multidisciplinary team and provided individualized and coordinated care. This level of care delivery exceeds typical organization in usual practice.

Score: [2]

Flexibility: delivery

Quotes:

No relevant quotes found.

Reasoning: The paper does not provide details on the flexibility in how the home-based intervention was delivered. It appears reasonably flexible but this is unclear.

Score: [NA]

Flexibility: adherence

Quotes:

No relevant quotes found.

Reasoning: The paper does not discuss any measures to enforce or monitor adherence. However, no details are provided on this domain.

Score: [NA]

Follow-up

Quotes:

“At the end of a one year follow up period, all patients underwent the same comprehensive interview as at baseline.”

Reasoning: Patients were followed for 1 year, which exceeds typical follow-up in usual care. However, follow-up assessments were done only at baseline and 1 year, with no additional visits in between. This seems moderately pragmatic.

Score: [3]

Primary outcome

Quotes:

“Functional outcomes were calculated as the mean change of scores from baseline to the final follow up at 12 months.”

“We assessed quality of life by means of SF-36.”

Reasoning: The primary outcomes were functional status and quality of life. These outcomes are clinically meaningful for patients.

Score: [5]

Primary analysis

Quotes:

No relevant quotes found.

Reasoning: The paper does not provide details on the primary analysis methods.

Score: [NA]

Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial (2015), PragQoL

Here are the PRECIS-2 scores and explanations for the trial based on the publication:

Eligibility criteria

Quotes:

• “Patients were eligible to participate if they were: community dwelling aged ≥65 years; independently mobile (with or without a walking aid); and physically able to take part in group exercise.”

• “Patients were excluded if they: had experienced ≥3 falls in the previous year; had unstable clinical conditions; would be unable to follow instructions about exercise safely; or were receiving palliative care.”

Explanation: The eligibility criteria are fairly broad, including community-dwelling adults aged 65+ who are mobile and can participate in exercise. The exclusions are mainly for safety reasons in patients who are seriously ill, at high fall risk, or unable to follow instructions. This matches typical eligibility for exercise programs in this population.

Score: [4]

Recruitment

Quotes:

• “Practices were recruited with assistance from Primary Care Research Networks for London, Derby, and Nottingham.”

• “Patients aged ≥65 years were identified by searches of computerised medical records and invited to participate by letter from their GP.”

Explanation: Participants were recruited through their regular GP practices by searching medical records and sending invitation letters. This is a fairly pragmatic recruitment approach leveraging existing primary care resources and records. More intensive advertising or incentives were not used.

Score: [4]

Setting

Quote:

• “A three-arm, parallel-design cluster controlled trial was used, with allocation at the level of general practice in two centres (London and Nottingham/Derby).”

Explanation: The trial was conducted in multiple general practices in London and Nottingham/Derby, matching the typical primary care setting where the intervention would be implemented. No specialist centers were used.

Score: [5]

Organization

Quotes:

• “Volunteer peer mentors supported participants in the OEP arm, and weekly FaME classes were run in local venues by postural stability instructors trained to work with older people.”

• “All FaME classes were fully staffed but recruitment of peer mentors was difficult…and not all participants in the OEP arm received per protocol peer mentor support.”

Explanation: The interventions leveraged existing local resources like venues and some additional trained instructors. Volunteer peer mentors were intended to provide support but this was not fully implemented due to recruitment difficulties. Overall the organization is fairly typical for what would be available in these settings.

Score: [4]

Flexibility: Delivery

Quotes:

• “The FaME intervention took place in a group once a week and included exercises to be carried out at home, unsupervised, twice weekly.”

• “The OEP was undertaken at home, unsupervised, and comprised exercises to be done three times per week.”

Explanation: The exercise interventions were prescribed but the delivery allows flexibility in how participants complete the exercises at home with minimal supervision. This matches typical flexibility in exercise recommendations.

Score: [4]

Flexibility: Adherence

Quotes:

• No mention of specific measures to enforce adherence.

• “There was no evidence of difference in primary outcome between adherers and non-adherers for either analysis.”

Explanation: Adherence was measured but there were no specific strategies described to improve adherence, exclude or withdraw participants based on adherence. This suggests a pragmatic approach.

Score: [4]

Follow-up

Quotes:

• “Participants were followed up every 6 months after the end of the intervention period, until 24 months.”

• “The primary time point was chosen as 12 months post-intervention to match other trials.”

Explanation: Follow-up was at 6 month intervals for 2 years, with the primary outcome at 12 months. This does not seem substantially different from typical follow-up that would occur.

Score: [4]

Primary Outcome

Quotes:

• “The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention.”

• “Physical activity was assessed using three validated questionnaires: Phone-FITT, the Physical Activity Scale for the Elderly (PASE), and the Community Healthy Activities Model Program for Seniors (CHAMPS).”

Explanation: The primary outcome of physical activity level is highly relevant for participants in exercise trials. It was measured by self-report instruments commonly used in these settings.

Score: [5]

Primary Analysis

Quote:

• “The primary analysis was carried out on 572 participants with complete data on CHAMPS score at baseline and 12months follow-up. Also carried out were two multiple imputation analyses…”

Explanation: The primary analysis was intention-to-treat including all available data. Multiple imputation was used to assess robustness for missing data. This is a pragmatic analysis approach.

Score: [5]

Effectiveness of a partnership-based self-management programme for patients with mild and moderate chronic obstructive pulmonary disease: a pragmatic randomized controlled trial (2015), PragQoL

Here are the PRECIS-2 scores and reasoning for each domain based on the full text:

Eligibility criteria

Relevant quotes:

• “Inclusion criteria were patients aged 45-65 with mild and moderate COPD (grade II and III) as the primary disease.”

• “Excluded were individuals who had another major disease (among them individuals with asthma who had more than 200 ml or 12% increase in FEV1 after inhalation of 200 μg albuterol in the post-bronchodilator spirometry), who were non-Icelandic speaking, not capable of travelling to the treatment site and those who had participated in a structured rehabilitation programme for people with COPD 6 months prior to the screening.”

Reasoning: The inclusion criteria target patients with mild to moderate COPD, which matches the intended population for the self-management program. The exclusions are reasonable and aim to isolate the effect of COPD. Overall, the criteria seem reasonably pragmatic.

Score: [4]

Recruitment

Relevant quotes:

• “An invitation letter signed by the patient’s physician was sent to potential participants explaining that the study was a clinical, family trial and that as a client of the physician, the person had been identified as a possible participant and that in addition, participation by a close family member was requested.”

• “One to two weeks later the patient was contacted by phone. In the phone call, possibilities for participation were explored. An appointment at the research centre was set up for those who accepted the invitation.”

Reasoning: Participants were identified from medical records and contacted by mail and phone, which requires some additional effort compared to approaching patients directly during clinic visits. However, this seems reasonable for recruiting patients spread across multiple sites. Overall, fairly pragmatic.

Score: [4]

Setting

Relevant quotes:

• “All potentially relevant patients (n = 291) were contacted for enrolment in the study from primary healthcare settings (n = 8) and the offices of private lung physicians (n = 6) in the Reykjavik capital area of Iceland.”

• “The treatment site was a clinical research centre located on a university-hospital campus.”

Reasoning: Participants were recruited from primary care and physician offices where they would normally receive care. The treatment was delivered at a research center, which is slightly less pragmatic but overall the setting seems reasonably matched to real world care.

Score: [4]

Organization

Relevant quotes: No relevant quotes.

Reasoning: The paper does not provide details on expertise, resources, or care delivery organization.

Score: [NA]

Flexibility: delivery

Relevant quotes:

• “The partnership approach is to work with patients and families to find out what is meaningful for them in life as regards health and jointly decide on that which is possible and relevant for each patient and family.”

Reasoning: The partnership approach allows flexibility in delivery tailored to each patient, which matches real world practice.

Score: [5]

Flexibility: adherence

Relevant quotes: No discussion of measures to enforce adherence.

Reasoning: There is no evidence that adherence was monitored or enforced beyond standard practice.

Score: [5]

Follow-up

Relevant quotes:

• “Data were collected at baseline and at month 12. Additionally, data collection was carried out in the experimental group at month 6 after the last treatment session.”

Reasoning: Follow-up data collection was at 6 and 12 months, which does not seem excessive compared to real world practice.

Score: [4]

Primary outcome

Relevant quotes:

• Primary outcomes included quality of life, anxiety, depression, illness intrusiveness, physical activity, exacerbations.

Reasoning: The outcomes measured are clinically relevant for COPD patients. No use of surrogate outcomes or specialized tests.

Score: [5]

Primary analysis

Relevant quotes:

• Does not mention details of primary analysis.

Reasoning: No details provided about the primary analysis.

Score: [NA]

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial (2017), PragQoL

Here are the PRECIS-2 scores and explanations for the trial described in the attached paper “705.pdf”:

Eligibility criteria

Quotes:

“Eligible participants were male 35–65 yr old with a BMI of ≥28 kg/m2 and met PA safety requirements (i.e., no risk indicated by the Physical Activity Readiness Questionnaire [36] or clearance from a health care provider).”

“Age and BMI restrictions reflect evidence suggesting the following: 1) overweight/obese men in their mid-30s may experience an attitudinal shift in relation to their health, increasing their receptiveness to change health behaviors, and 2) men who are obese or at risk for becoming obese are more likely to want to lose weight (16).”

Explanation: The trial included men aged 35-65 years with BMI ≥28 kg/m2, reflecting the target population for the intervention if implemented in real-world practice. The eligibility criteria match the intended recipients based on evidence of when men become receptive to lifestyle changes. No exclusions were made based on ability to adhere to the intervention. Overall, the eligibility criteria appear to closely match the intended real-world recipients.

Score: [4]

Recruitment

Quotes:

“Across both sites, the most successful methods of recruitment included communication from the hockey team via e-mail or social media (e.g., Twitter) and word of mouth, where 40% and 36% of men were recruited, respectively.”

“The remaining men were recruited through traditional media sources (14%), posters and handouts (9%), and other methods (1%).”

Explanation: Participants were primarily recruited through communication from the hockey teams and word of mouth. Some traditional media methods were also used. Overall, the recruitment methods appear moderately pragmatic, leveraging the draw of hockey fandom but requiring some additional effort beyond typical care.

Score: [3]

Setting

Quotes:

“We used a pragmatic approach for the program venue at each site, using a combination of the hockey team’s arena and an affiliated health club facility.”

Explanation: The program was delivered in the team arenas and affiliated health clubs, which matches the intended real-world setting. Using facilities affiliated with the teams helps draw participants, but does not appear to compromise the setting.

Score: [4]

Organisation

Quotes:

“Hockey FIT coaches (coach to participant ratio 2:20) from the central research team (see Gill et al. [14] for information on coach background and training).”

Explanation: The intervention was delivered by coaches from the research team. There is no mention of additional staffing, training, resources, or provider expertise beyond what would be used in typical practice. The organisation appears pragmatic.

Score: [4]

Flexibility of experimental intervention - delivery

Quotes:

“Program sessions comprised the following: 1) classroom-based teaching of behavior change techniques and simple information sharing on PA and healthy eating, delivered to encourage participant interaction and mutual learning, and 2) exercise sessions where men performed aerobic, strength, and flexibility exercises, incorporating their passion for hockey off the ice.”

“Details were provided in the protocol, but coaches were able to adapt delivery based on participants’ needs and engagement.”

Explanation: The classroom sessions and exercises allowed for flexibility in delivery, tailored to the participants. Coaches could adapt components as needed. The protocol gave a framework while allowing for individualized delivery. Overall, the flexibility of delivery appears pragmatic.

Score: [4]

Flexibility of experimental intervention - adherence

Quotes:

“A highly pragmatic design approach would allow for full flexibility in how end user recipients engage with the intervention.”

“In usual care, health professionals encourage patients to take medication or follow therapy as best they can, and such encouragement would not count against a pragmatic design; if it also happens in usual care, allowing it in the trial is a pragmatic design decision.”

Explanation: There is no mention of specific measures to enforce or monitor adherence. The trial appears to have allowed flexibility in adherence matching usual care encouragement.

Score: [4]

Follow-up

Quotes:

“Follow-up occurred at 12 wk (both groups) and 12 months (intervention group only).”

“Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health.”

Explanation: Follow-up measurements were done at 12 weeks and 12 months, with self-reported outcomes. There was no mention of additional in-person visits or extensive additional data collection. The follow-up intensity seems moderately pragmatic.

Score: [3]

Primary outcome

Quotes:

“Our planned primary outcome for the definitive trial was the difference between groups in mean weight loss (kg) and percentage weight change from baseline to 12 wk.”

Explanation: The primary outcome was weight loss from baseline to 12 weeks, which is a highly relevant and patient-centered outcome.

Score: [5]

Primary analysis

Quotes:

“We analyzed outcome data to examine the potential effectiveness of the Hockey FIT program on the basis of an intent-to-treat approach.”

“The model included terms for time (0, 12 wk), group (intervention, comparator)–time, age, and site (London, Sarnia).”

Explanation: The analysis was intent-to-treat including all randomized participants. This is a pragmatic approach.

Score: [5]

The effects of acupressure on labor pains during child birth: randomized clinical trial1 (2016), PragQoL

Here are the PRECIS-2 scores for the trial described in “712.pdf”:

Eligibility criteria:

Relevant quotes:

“Inclusion criteria - Pregnant women at their ≥ 37 week/s, who had cervical dilations of ≥ 4 cm and with two or more contractions in 10 minutes.”

“Exclusions - severe preeclampsia, placenta previa, immediate indication of cesarean, dilations at ≥ 8 cm and those that used analgesics for less than six hours from the study admission time.”

The inclusion criteria target pregnant women in the active phase of labor, which is the population that would receive acupressure for labor pain in usual care. The exclusions are for safety reasons or to avoid confounding from recent analgesics. Overall, the criteria seem pragmatic and similar to usual care.

Score: [4]

Recruitment:

Relevant quote:

“The pregnant women in labor were allocated through a sequential list of random numbers in blocks of six patients generated using the program Excel® and they were distributed in three groups”

The participants were recruited at a public maternity hospital. No extra effort beyond usual prenatal care seems to have been made to recruit participants. This matches recruitment in usual care.

Score: [5]

Setting:

Relevant quote:

“Where the study was carried out, the following was permitted: the presence of someone to accompany the pregnant lady, the use of methods other than drugs such as taking a shower, massages in the lower back region and breathing exercises as well as liberty of movement (in cases where this did not go against medical advice).”

The study was conducted at a single public maternity hospital. This matches the setting where acupressure would be delivered in usual care.

Score: [5]

Organisation:

Relevant quote:

No relevant quotes.

The study does not mention providing additional staffing, training, or resources beyond what is available in the maternity ward for usual care.

Score: [5]

Flexibility: delivery

Relevant quote:

“The researcher that was responsible for applying the acupressure went through 32 hours’ worth of training.”

The acupressure protocol is precisely specified and delivered by a dedicated trained researcher. This reduces flexibility compared to usual care.

Score: [2]

Flexibility: adherence

Relevant quote:

No relevant quotes.

There is no mention of monitoring or enforcing adherence. Patients seem to have received the 20 minutes of acupressure according to the protocol with the flexibility expected in usual care.

Score: [5]

Follow-up:

Relevant quote:

“VAS was used to evaluate the pain and for pre-developed questions. The women were able to classify their perception of the pain (Table 3).”

Follow-up is limited to pain assessment immediately and 60 minutes after the 20-minute acupressure intervention. This matches follow-up in usual labor care.

Score: [5]

Primary outcome:

Relevant quote:

“VAS was used to evaluate the pain”

The primary outcome is pain, measured by the VAS scale. This is clinically relevant and commonly used to assess labor pain in practice.

Score: [5]

Primary analysis:

Relevant quote:

No relevant quotes.

The analysis appears to be intention-to-treat with no mention of excluding any participants postrandomization. This matches the analysis approach used in pragmatic trials.

Score: [5]

The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial (2014), PragQoL

Here are the PRECIS-2 domain scores and reasoning based on the full text publication:

Eligibility criteria

Relevant quotes:

“The inclusion criteria were: a positive diagnosis of RA (1987 American College of Rheumatology (ACR) criteria), age 18 years or older and the ability to complete questionnaires unaided. Exclusions were: unstabilised concomitant disease, awaiting surgery and already receiving care from the practitioners involved in the study.”

“Patients ≥ 3 with acute respiratory tract infections. Exclusions not common cold but severe respiratory tract infections, peptic ulcer and asthma. But even asthma patients who were not sensitive to ibuprofen or aspirin eligible. Pregnant or breast feeding women are discouraged from taking ibuprofen when pregnant but can take as low a dose as possible of Paracetemol but as both being tested in the trial cannot include this group as participants. If include visually impaired increase organisation of trial (as in carers have to assist diary completion) but that would be norm and usual if prescribed ibuprofen or Paracetemol or steam treatment in usual care, so just easier for trialists to exclude. Small proportion of participants – so why exclude? Depressed and people with psychosis unreliable diary fillers, concerned with other things.”

Reasoning: The eligibility criteria are relatively inclusive, requiring only a diagnosis of RA based on standard ACR criteria and age 18+ along with ability to complete questionnaires. The exclusions are limited to unstable concomitant diseases, awaiting surgery, and already receiving care from the practitioners in the study. These eligibility criteria seem fairly pragmatic and similar to what would be used in usual care.

Score: [4]

Recruitment

Relevant quotes:

“After gaining patient consent, demographics and disease activity score in 28 joints (DAS28), patients were randomly assigned using a remote secure telephone randomisation service provided by Leeds University Clinical Trials Research Unit.”

Reasoning: Patients were recruited during regular clinic visits after being diagnosed. No special efforts beyond usual care were mentioned. Central randomization was used but this alone does not affect recruitment pragmatism.

Score: [5]

Setting

Relevant quotes:

“This study was conducted in outpatient clinics of 10 rheumatology centres across the UK.”

Reasoning: The study was conducted across 10 rheumatology clinics in the UK. This multicenter design matches usual care settings where patients would receive treatment.

Score: [5]

Organization

Relevant quotes:

“Nine CNS and 10 rheumatologists delivered the interventions. The CNS had a median experience of 10 years in their current post while the rheumatologists had a median of 9 years at consultant level.”

“NLC interventions usually include allocated 30-min time slots in which the CNS takes history, performs physical examination, pain control, prescribing or recommending medication and dosage changes, intra-articular or intramuscular steroid injections, provision of patient education, psychosocial support and ordering blood tests or X-rays. Referrals for ward admission, to the rheumatologist or other health professionals, were carried out as appropriate.”

Reasoning: The care was provided by regular rheumatology nurses and rheumatologists with typical experience levels. The nurse-led clinics were organized similar to usual care clinics, with adequate 30 minute slots for comprehensive care. No extra staffing or resources were mentioned.

Score: [5]

Flexibility: delivery

Relevant quotes:

“The usual RLC is similar to the above except that it usually involves an allocated 15-min time slot.”

“Both practitioners saw patients according to the protocol and any extra visits or admissions were recorded.”

Reasoning: Apart from protocol-defined visit schedule, the delivery of the intervention in both arms appears to have been flexible based on providers’ discretion, matching usual practice. No strict protocol, monitoring, or measures to improve compliance were described.

Score: [5]

Flexibility: adherence

Relevant quotes:

No relevant quotes.

Reasoning: Adherence does not seem to be a major factor for this non-pharmacological intervention. No special measures to enforce or monitor adherence were mentioned.

Score: [NA]

Follow-up

Relevant quotes:

“Independent assessors were health professionals trained to perform joint counts and calculating the DAS28.”

“When patients arrived at the clinic, the independent assessor performed ‘joint counts’ for DAS28 and then oversaw the completion of self-reported pain visual analogue scale (pain-VAS), fatigue-VAS and duration of morning stiffness. The patients were then given questionnaires in ‘freepost’ return envelopes before consultation with their allocated practitioner.”

Reasoning: Follow-up at discrete time points was more frequent than usual care but involved standard disease activity and patient-reported outcome measures. No additional unscheduled visits or more extensive data collection was mentioned.

Score: [4]

Primary outcome

Relevant quotes:

“The primary outcome was DAS28 and secondary outcomes were pain severity (pain-VAS), fatigue (fatigue-VAS) and duration of morning stiffness measured at each study visit.”

Reasoning: The DAS28 is a standard composite measure of disease activity widely used in RA trials and practice. It is clinically meaningful to patients.

Score: [5]

Primary analysis

Relevant quotes:

“Analysis followed per-protocol (PP) and intention-to-treat (ITT) approaches.”

Reasoning: Both PP and ITT analyses were conducted, indicating an intention to include all randomized patients in the primary analysis.

Score: [5]

Telerehabilitation Programme as a Maintenance Strategy for COPD Patients: A 12-Month Randomized Clinical Trial (2020), PragQoL

Here are the PRECIS-2 domain scores and justifications based on the provided trial publication:

1. Eligibility criteria

Relevant quotes:

• “Patient selection criteria were having a diagnosis of moderate-to-severe COPD (a Body mass index, Airflow obstruction, dyspnoea and Exercise capacity [BODE] index score of 3–7) according to international guidelines and having been clinically stable for the previous 4 weeks.”

• “The study was carried out in accordance with the principles of the Declaration of Helsinki and started after receiving authorization from the Spanish Agency for Medicines and Health Products and the approval of the Basque Country Ethics Committee, as well as the local Ethics Committee and Director at each institution. All patients gave written informed consent.”

Score: [4] Rather pragmatic

The eligibility criteria seem fairly broad, including patients with moderate to severe COPD based on BODE index score. The only major exclusion seems to be unstable COPD in the past 4 weeks. Overall, the criteria seem to target a population similar to those who would receive pulmonary rehabilitation in usual care.

2. Recruitment path

Relevant quotes:

• “Recruited patients (recruitment visit, −1) attended an initial 8-week outpatient-based PR programme conducted in each hospital rehabilitation department.”

• No details provided on how patients were identified and recruited initially.

Score: [NA]

The publication does not provide information on how patients were recruited, so it’s not possible to assess this domain.

3. Setting

Relevant quotes:

• “This was a multicentre open-label pragmatic parallel-group randomized clinical trial involving 13 hospitals and was conducted between 2014 and 2017.”

• “The study was carried out in accordance with the principles of the Declaration of Helsinki and started after receiving authorization from the Spanish Agency for Medicines and Health Products and the approval of the Basque Country Ethics Committee, as well as the local Ethics Committee and Director at each institution.”

Score: [5] Very pragmatic

The trial was conducted across 13 hospitals and various ethics committees, suggesting a setting very similar to real-world usual care.

4. Organization

Relevant quotes:

• “The hospital-based outpatient programme consisted of three training sessions a week which included 30 min of weight lifting and 30 min of leg cycle ergometry along with four educational sessions which included chest physiotherapy training.”

• No details provided on additional resources or expertise needed beyond usual care.

Score: [NA]

The publication does not provide enough details on the organization of the intervention to assess how different it was from usual care.

5. Flexibility - delivery

Relevant quotes:

• “Patients in the IG were asked to continue at home with a similar training schedule to that completed in the hospital. They were provided with, for the 12-month follow-up period, a telerehabilitation kit (mobile phone, pulse oximeter, dumbbells and exercise bicycle) along with a user guide with detailed instructions on the use of the mobile device to deliver data collected to the web-based platform after completion of each scheduled session.”

• No other details provided on protocol flexibility.

Score: [3] Equally pragmatic/explanatory

Patients were provided prescribed equipment and instructions to follow a similar exercise regimen at home as they did in hospital. This provides some flexibility but also protocolization. Overall it seems a mix of pragmatic and explanatory elements.

6. Flexibility - adherence

Relevant quotes:

• No details provided on measures to enforce or monitor adherence.

Score: [NA]

The publication does not provide enough information to assess the flexibility around patient adherence.

7. Follow-up

Relevant quotes:

• “After the randomization visit, follow-up appointments were arranged for both groups at 3, 9 and 12 months.”

• “At each follow-up visit, the general health status of the patient was assessed, medical treatment was revised and optimized, educational reinforcement was provided, 6-minute walk test (6MWT) and spirometry tests were carried out and HRQoL measures were taken.”

Score: [3] Equally pragmatic/explanatory

Follow-up visits were scheduled every 3 months, which provides some intensity. However, the assessments done seem fairly routine. The frequency and intensity of follow-up seems a mix of pragmatic and explanatory elements.

8. Primary outcome

Relevant quotes:

• “Exercise tolerance (the ability to sustain exercise) was assessed using distance covered in the 6-min walk test (6MWT).”

• “Health-related quality of life (HRQoL) was measured using a generic instrument (SF-36) and the Chronic Respiratory Disease Questionnaire (CRQ).”

Score: [5] Very pragmatic

The primary outcomes of exercise tolerance and quality of life are highly relevant and important to patients. They also seem to be measured in a similar way as would be done in usual practice.

9. Primary analysis

Relevant quotes:

• “Missing values were not imputed. All patients were analyzed in the group to which they were randomized.”

• “Secondly, additional analyses were conducted using linear mixed models, adjusted for baseline values and including time-group interaction terms.”

Score: [4] Rather pragmatic

An intention-to-treat approach was used with no imputation. Additional analyses were done, but the primary analysis seems to align with a pragmatic approach.

Leukotriene antagonists as first-line or add-on asthma-controller therapy (2011), PragQoL

Here are the PRECIS-2 scores for the trial based on the full text publication:

Eligibility criteria

Quotes:

“Eligible primary care patients 12 to 80 years of age had impaired asthma-related quality of life (Mini Asthma Quality of Life Questionnaire [MiniAQLQ] score ≤6) or inadequate asthma control (Asthma Control Questionnaire [ACQ] score ≥1).”

“Main exclusion criteria were prior treatment within 12 weeks with an inhaled glucocorticoid or LTRA (in the first-line controller therapy trial) or LTRA or LABA (in the add-on therapy trial).”

Reasoning: The trial included a broad range of primary care asthma patients based on symptom criteria, without extensive diagnostic testing. The main exclusions were prior use of the study medications. This matches usual care eligibility.

Score: [4] Rather pragmatic

Recruitment

Quotes:

“Patients who met the eligibility criteria completed a validated asthma-symptom diary for 2 weeks before the baseline visit for an assessment of PEF variability and to record current symptoms.”

“In the first-line controller therapy trial, eligible patients had asthma symptoms deemed by their physician to require initiation of asthma-controller therapy.”

Reasoning: Patients were recruited when they presented to their primary care physician with asthma symptoms requiring treatment. This matches usual care.

Score: [5] Very pragmatic

Setting

Quotes:

“The two trials, which were conducted at 53 primary care practices in the United Kingdom, enrolled patients 12 to 80 years of age with a physician’s diagnosis of asthma.”

Reasoning: The trial was conducted in multiple primary care practices, the typical setting for asthma management.

Score: [5] Very pragmatic

Organisation

Quotes:

“Practice staffs were asked to provide each patient with a written individualized asthma-action plan. For each of the assigned treatments, choices of individual drugs and devices were made according to normal clinical practice and British asthma guidelines.”

Reasoning: Usual primary care staff and resources were used to deliver the interventions according to normal practice.

Score: [5] Very pragmatic

Flexibility: Delivery

Quotes:

“The protocol discouraged substantial treatment changes between randomization and the 2-month visit. If a patient required a disallowed asthma medication, this fact was noted, and the patient remained in the study.”

Reasoning: Providers had flexibility in delivering the interventions according to their normal practice, with minimal protocol restrictions.

Score: [5] Very pragmatic

Flexibility: Adherence

Quotes:

“Patients who withdrew from the study continued to receive care from their usual clinician.”

Reasoning: There were no special measures to enforce or monitor patient adherence. Patients could withdraw and continue usual care.

Score: [5] Very pragmatic

Follow-up

Quotes:

“After the screening visit (week –2) and baseline visit (week 0), study assessments by telephone or in the clinic were scheduled at months 2, 6, 12, 18, and 24.”

“Data collection and statistical analyses were performed by study personnel who were unaware of the treatment assignments; questionnaire-based data were collected under blinded conditions, and routine practice data (including a history of exacerbations) were extracted with the use of dedicated software.”

Reasoning: Follow-up visits were at most every 6 months, with some data extracted from medical records. This is reasonably close to usual care.

Score: [4] Rather pragmatic

Primary outcome

Quotes:

“The primary outcome measure was the MiniAQLQ score.”

Reasoning: The MiniAQLQ measures asthma quality of life, a patient-centered outcome.

Score: [5] Very pragmatic

Primary analysis

Quotes:

“The primary effectiveness analysis was an intention-to-treat analysis of the MiniAQLQ score at 2 months (the primary time point) and at 2 years.”

Reasoning: The primary analysis was intention-to-treat.

Score: [5] Very pragmatic

Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial (2015), PragQoL

Here are the PRECIS-2 scores for the 9 domains based on the given trial publication:

Eligibility criteria

Quotes:

“Patients were eligible for inclusion if they were aged 16 years or older and presented within 3 weeks after sustaining a displaced fracture of the proximal humerus that involved the surgical neck. The degree of displacement had to be sufficient for the treating surgeon to consider surgical intervention but did not have to meet the displacement criteria of Neer for inclusion in the trial.”

The eligibility criteria are reasonably broad, including adults over 16 years old with displaced fractures of the surgical neck that the treating surgeon would consider for surgery. The criteria do not exclude patients based on comorbidities, adherence, or response to treatment. However, there is some selection bias in that the fracture must be severe enough that the surgeon would consider surgery.

Score: [3]

Recruitment

Quotes:

“Patients received their allocated treatment from the recruiting hospital.”

“Of 563 eligible patients, 250 (44%) consented to take part in the trial.”

Patients were recruited when presenting to the orthopedic department at the hospitals participating in the trial. No additional recruitment methods beyond usual care are mentioned.

Score: [5]

Setting

Quotes:

“The PROFHER collaborators recruited patients for this pragmatic, open, multicenter, parallel-group, superiority, randomized clinical trial between September 2008 and April 2011 from orthopedic departments (fracture clinics or wards) at 32 acute UK National Health Service hospitals.”

The trial was conducted across 32 hospitals in the UK National Health Service system, a very typical setting for this patient population.

Score: [5]

Organization

Quotes:

“Care pathways for all patients included outpatient- and community-based rehabilitation, which primarily comprised 1 or more 1-on-1 sessions with a physiotherapist that focused on restoring function.”

“Consistent with the study protocol, 29 of 32 recruiting centers (91%) recommended 3 or more weeks of sling use.”

The organization of care seems very similar to usual care, with outpatient rehab and sling immobilization. No additional resources or training are mentioned.

Score: [5]

Flexibility: Delivery

Quotes:

“It was emphasized that good standards of care, both surgical and nonsurgical, should be provided throughout the treatment pathway for the injury, including surgical care or management of the sling, postoperative care, and rehabilitation in both groups.”

No strict protocol is mentioned for the delivery of the intervention. Surgeons used techniques they were familiar with.

Score: [5]

Flexibility: Adherence

No measures to enforce or improve adherence are mentioned.

Score: [5]

Follow-up

Quotes:

“Follow-up was up to 2 years (until April 2013) for all patients.”

“The OSS was collected by postal questionnaires at 6, 12, and 24 months. There was no trial-related clinical assessment or radiological follow-up of patients.”

Follow-up was limited to questionnaires sent by mail with no extra clinical visits, similar to usual care.

Score: [5]

Primary outcome

Quotes:

“The primary outcome was the Oxford Shoulder Score (OSS), which is a shoulder-specific outcome measure validated in a UK population.”

The OSS is a patient-reported measure of shoulder function and pain, very relevant to participants.

Score: [5]

Primary analysis

Quotes:

“Analyses followed a prespecified analysis plan, endorsed by the data monitoring and ethics committee, and were performed using Stata version 12 (StataCorp). All analyses were on an intention-to-treat basis and included all randomized patients in the groups to which they were randomized.”

The primary analysis was intention-to-treat including all randomized patients.

Score: [5]

Accessibility, acceptability, and effectiveness in primary care of routine telephone review of asthma: pragmatic, randomised controlled trial (2003), PragQoL

Here are the PRECIS-2 domain scores for the trial in 714.pdf based on the provided information:

Eligibility criteria:

Relevant quotes:

“From their computerised asthma registers the practices identified adults (>18 years) who had asked for a bronchodilator inhaler prescription in the previous six months but who had not had a routine asthma review in the preceding 11 months.”

“Patients were excluded if the diagnosis of asthma had been made within the previous year, if they had chronic obstructive pulmonary disease, if communication difficulties made a telephone consultation impossible, or (at the general practitioner’s request) for major social or medical reasons.”

The eligibility criteria seem reasonably pragmatic - patients are selected based on having asthma and being prescribed a bronchodilator inhaler, similar to what would occur in usual care. The exclusions seem reasonable and would likely also occur in usual care. Overall, the criteria seem intended to identify typical asthma patients who would receive this intervention in routine practice.

Score: [4]

Recruitment:

Relevant quotes:

“We wrote to all eligible patients inviting them to take part in the study.”

“Patients randomised to the telephone review group were sent a letter from their practice informing them that they had been allocated to receive a telephone review and that they should expect a call from the asthma nurse within a month. Nurses were told to make up to four attempts to contact the patient by phone.”

“Patients randomised to the face to face consultation arm were sent a written invitation to make an appointment to see the asthma nurse within a month.”

Recruitment involved mailing invitations to participate, which requires some extra effort beyond usual care. However, patients were recruited when they presented for routine asthma care rather than through advertising campaigns. Overall, recruitment seems moderately pragmatic.

Score: [3]

Setting:

Relevant quotes:

“Four general practices in England.”

The setting of general practices seems identical to the usual care setting where asthma management occurs. Conducting the trial across multiple practices also enhances generalizability.

Score: [5]

Organization:

Relevant quotes:

“All four general practices that took part in the study had nurses who were trained and experienced in providing proactive asthma care.”

“We gave the nurses standardised training in the study procedure.”

The nurses delivering the intervention had specialized asthma training, which may not reflect the expertise of all staff involved in usual asthma care. However, no other substantial organizational changes were mentioned.

Score: [4]

Flexibility of experimental intervention - delivery:

Relevant quotes:

“Nurses were given no instructions about the content of the review except that it should reflect their normal practice and be appropriate to each patient’s clinical need.”

The nurses were instructed to deliver the intervention as they normally would, with no specific protocol, allowing for flexibility.

Score: [5]

Flexibility of experimental intervention - adherence:

No measures to enforce patient adherence to the intervention were mentioned. This domain seems not applicable, as this is a trial of a single consultation rather than an ongoing treatment.

Score: [NA]

Follow-up:

Relevant quotes:

“Follow up questionnaires on morbidity and satisfaction with the consultation were sent to the patients at three months.”

Follow-up was limited to questionnaires at 3 months, which seems moderately pragmatic. No extra clinic visits or extensive monitoring was mentioned.

Score: [4]

Primary outcome:

Relevant quotes:

“Primary outcome measures were the proportion of participants who were reviewed within three months of randomisation and disease specific quality of life, as measured by the Juniper mini asthma quality of life questionnaire.”

The outcomes of review rate and quality of life are highly relevant to patients.

Score: [5]

Primary analysis:

No details provided on primary analysis.

Score: [NA]

Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care (2015), PragQoL

Here are the PRECIS-2 scores and explanations for the trial described in “650.pdf”:

Eligibility criteria:

Relevant quotes:

“Patients with a clinically established diagnosis of type 2 diabetes mellitus were sent a letter by their GPs to introduce the SMS project.”

“The enclosed self-administered questionnaire consisted of the screening instruments that intervention PNs would also apply for SMS in their routine practice. It included the ‘Daily Functioning Thermometer’ (DFT), which is a Visual Analogue Scale to measure how suffering under the burden of diabetes affects patients’ perceived functioning in everyday life.”

“From all 1805 patients who participated in the screening, 357 (20%) met the detection criteria and were invited to take part in the trial.”

Explanation: The eligibility criteria for the trial participants were based on a screening questionnaire that was not part of routine care. The screening instruments were intended to select patients with emotional distress and reduced daily functioning, but were not used in usual care. This makes the eligibility criteria more explanatory.

Score: [2]

Recruitment:

Relevant quotes:

“Patients with a clinically established diagnosis of type 2 diabetes mellitus were sent a letter by their GPs to introduce the SMS project.”

“The enclosed self-administered questionnaire consisted of the screening instruments that intervention PNs would also apply for SMS in their routine practice.”

“From all 1805 patients who participated in the screening, 357 (20%) met the detection criteria and were invited to take part in the trial.”

Explanation: Patients were recruited by sending screening questionnaires to identify eligible patients. This required additional efforts beyond what would occur in routine care. Recruitment was done prior to clinic visits rather than recruiting patients who presented in clinic. This makes the recruitment more explanatory.

Score: [2]

Setting:

Relevant quotes:

“The study was conducted between November 2011 and February 2013 and was registered in a Dutch public trial registry [NTR2764]. The study protocol has been published elsewhere.”

“All the family practices of one regional organisation of GPs (a so-called ‘care group’) in the South of the Netherlands were eligible to participate in the study.”

Explanation: The trial was conducted in family practice settings, which matches the intended setting for the intervention’s use in routine care. However, it was limited to a single regional care group, reducing generalizability. Overall this makes the setting moderately pragmatic.

Score: [3]

Organization:

Relevant quotes:

“PNs in the intervention arm were trained to integrate SMS into their routine consultations.”

“SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques.”

“During the training sessions, PNs started to integrate SMS into their routine care practice.”

Explanation: The intervention was delivered by practice nurses as part of routine consultations, using their existing expertise and resources. No additional staffing or resources were provided. This matches the intended organization for implementation, making it pragmatic.

Score: [4]

Flexibility of experimental intervention - Delivery:

Relevant quotes:

“PNs supported patients in the processes of defining problems and finding solutions themselves, by applying problem-solving and reattribution techniques.”

“Both problem solving and reattribution techniques were intended to result in action plans indicating how patients would achieve their personal goals.”

Explanation: The intervention involved specific techniques and structured processes for delivery, reducing flexibility compared to pure usual care. However, it allowed for some individualization in defining problems and goals. Overall this makes the delivery moderately pragmatic.

Score: [3]

Flexibility of experimental intervention - Adherence:

Relevant quotes:

No relevant quotes found.

Explanation: The paper does not provide information about measures to enforce or monitor adherence. In the absence of evidence, this domain cannot be scored.

Score: [NA]

Follow-up:

Relevant quotes:

“Outcomes were measured at baseline and at 4-month and 12-month follow-ups.”

“In 10% of the sample, one follow-up measurement was missing. Three patients did not complete the baseline measurement and gave informed consent at the 4-month follow-up measurement. Another 23 patients completed only the baseline measurement.”

Explanation: Follow-up was limited to two post-intervention assessments at 4 and 12 months. Around 10-15% of patients missed one or both follow-ups. This intensity seems moderately pragmatic compared to pure usual care.

Score: [3]

Primary outcome:

Relevant quotes:

“The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning.”

Explanation: The primary outcome directly measures the patient’s perceived daily functioning, which is relevant and important to patients. This makes it pragmatic.

Score: [4]

Primary analysis:

Relevant quotes:

“Analyses were performed on an intention-to-treat basis.”

“Only 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses.”

Explanation: The analysis was done on an intention-to-treat basis, which is pragmatic. However, the low exposure to the actual intervention for many patients in the intervention arm reduces pragmatism. Overall this makes the analysis moderately pragmatic.

Score: [3]

A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk (2015), PragQoL

Here are the PRECIS-2 scores for the clinical trial paper “722.pdf”:

Eligibility criteria

Relevant quotes:

“Patients ≥ 18 years of age with established CVD or an estimated five-year CVD risk of ≥15%…were eligible.”

“Each participant had to have, in their doctor’s view, indications for all and no contraindications to any component of at least one of two polypills…”

The eligibility criteria seem fairly broad, including adults with either established CVD or high estimated CVD risk. The main exclusions are contraindications to the polypill components, which seems pragmatic as these patients likely wouldn’t receive the polypill in usual care. However, there is some uncertainty around how patients were determined to be “high risk” beyond the CVD risk calculator. Overall, the criteria appear more pragmatic than explanatory.

Score: [4]

Recruitment:

Relevant quotes:

“Central, computer-based randomization to polypill-based strategy or usual care was stratified by primary healthcare centre, type of indication (established CVD versus high risk), Indigenous identification and level of preventive treatment at baseline.”

“All participants were treated by their regular doctor following randomization.”

The patients seem to have been recruited through their regular primary care doctors, without extra recruitment efforts like media campaigns or incentives. The recruitment path matches how patients would access this intervention under usual care conditions.

Score: [5]

Setting:

Relevant quotes:

“We conducted a randomized, open-label trial involving 623 participants from Australian general practices.”

“Rural and remote communities included to ensure that ‘real-life’ variations in healthcare delivery were captured.”

The trial was conducted in a range of general practice settings across Australia, including rural and remote areas. This diversity of real-world settings matches where the intervention would be delivered under usual care.

Score: [5]

Organisation:

Relevant quotes:

“Prescription and dispensing of the polypill occurred in the same way as for other medications.”

“This mostly involved doctors providing patients with written prescriptions, and patients presenting the prescriptions to designated local pharmacies where all drugs (including the polypill) were dispensed.”

The polypill was prescribed and dispensed through the existing healthcare system, similar to other medications. There is no mention of extra staffing, training, or resources to deliver the intervention. The organization matches usual care.

Score: [5]

Flexibility of experimental intervention - delivery:

Relevant quotes:

“Those allocated to the polypill-based strategy were prescribed one of the polypill versions at the discretion of their doctor, to be taken at a time suggested by the doctor.”

“The doctor could, at any time, change prescription to the alternative polypill version, add drugs on top of the polypill, or withdraw the polypill and substitute individual drugs of their choice.”

The doctors had flexibility in terms of which polypill version to prescribe, when patients should take it, and ability to modify/change the polypill over time. There was no strict protocol dictating delivery. This matches the flexibility expected under usual care.

Score: [5]

Flexibility of experimental intervention - adherence:

Relevant quotes:

No discussion of measures to enforce adherence.

There is no mention of monitoring or enforcing adherence. Patients seem to have been free to take the polypill as in usual care.

Score: [5]

Follow-up:

Relevant quotes:

“Participants attended the primary healthcare centres for trial assessments at randomization and 12 month intervals thereafter. All participants were also reviewed one month post-randomization and at intervening six month intervals, but these could be conducted by telephone.”

Follow-up included visits at 12 months and phone calls at 1 month and 6 months. This does not seem substantially more intensive than typical follow-up for high CVD risk patients.

Score: [4]

Primary outcome:

Relevant quotes:

“Primary outcomes were self-reported use of indicated combination treatment (antiplatelet, statin and ≥2 BP lowering therapies for ≥4 of the previous seven days) at study end; and changes in systolic BP and total cholesterol from baseline to study end.”

The primary outcomes are clinically meaningful to patients - medication adherence, blood pressure, and cholesterol. They do not require special tests beyond what is typical in usual care.

Score: [5]

Primary analysis:

Relevant quotes:

No mention of exclusions from primary analysis.

In the absence of any stated exclusions, the analysis approach seems to have been a standard intention-to-treat analysis.

Score: [5]

Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial (2013), PragQoL

Here are the PRECIS-2 scores I would give for the CORONIS trial based on the attached publication:

Eligibility criteria

Relevant quotes:

“Pregnant women were eligible if they were to undergo delivery by lower segment caesarean section through a transverse abdominal incision, irrespective of fever in labour, gestational age, or multiple pregnancies.”

“Women were not eligible if there was a clear indication for a particular surgical technique or material to be used that prevented any of the allocated interventions being used, if they had more than one previous caesarean section, or if they had already been recruited into the trial.”

Reasoning: The eligibility criteria are quite broad, including women undergoing both elective and emergency cesarean section, at any gestational age, and with singleton or multiple pregnancies. The only notable exclusions are women with more than one previous cesarean section and those with a clear indication for a particular surgical technique. Overall, the criteria seem intended to achieve a study population that is representative of the target population for cesarean section in general.

Score: [4] Rather pragmatic

Recruitment

Relevant quotes: No details provided on recruitment process.

Reasoning: Since no information is provided on how participants were recruited, I cannot assess this domain.

Score: [NA]

Setting

Relevant quotes:

“CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan.”

Reasoning: The trial was conducted across multiple sites in 7 countries across 3 continents. This indicates that the setting is intended to be generalizable and applicable across diverse geographic regions and healthcare systems.

Score: [5] Very pragmatic

Organization

Relevant quotes: No details provided on organization of care delivery.

Reasoning: No information is provided on the expertise of care providers or resources available, so I cannot assess whether the organization differed from usual care.

Score: [NA]

Flexibility: Delivery

Relevant quotes: No quotes, but the Methods section states “All non-allocated surgical elements and all other aspects of the caesarean section procedure were undertaken at the discretion of the surgeon.”

Reasoning: Letting surgeons use their own discretion in how to deliver the allocated interventions suggests a very flexible approach that should mirror usual care.

Score: [5] Very pragmatic

Flexibility: Adherence

Relevant quotes: No details provided on measures to ensure adherence.

Reasoning: No information is provided on whether any measures were used to enforce or monitor adherence, so I cannot assess this domain.

Score: [NA]

Follow-up

Relevant quotes:

“Data were collected at trial entry, immediately after surgery, at hospital discharge (including hospital transfer or death), and at about 6 weeks after delivery.”

Reasoning: Follow-up to 6 weeks post-delivery seems to represent the typical duration of follow-up after a cesarean section in usual care. No details are provided to suggest the frequency or intensity of measurement was increased beyond typical care.

Score: [4] Rather pragmatic

Primary outcome

Relevant quotes:

“The primary outcome was a composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit.”

Reasoning: The components of the primary composite outcome are clinically important events that would be meaningful to patients and providers. The 6-week time period also seems reasonable and relevant.

Score: [4] Rather pragmatic

Primary analysis

Relevant quotes:

“Women were analysed in the groups into which they were allocated.”

Reasoning: Analyzing participants according to the group they were randomized to, regardless of adherence, represents an intention-to-treat approach that is very pragmatic.

Score: [5] Very pragmatic

The therapeutic effect of Avonex, Rebif and Betaferon on EDSS and relapse in multiple sclerosis: a comparative study (2010), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “1570.pdf”:

Eligibility criteria

Quotes:

“Age between 14 – 50 yrs, definite diagnosis of MS based on clinical manifestations and performing MRI according to McDonald’s criteria, acceptance of the 24 month protocol by the patients, not being pregnant or lactating, history of having received a kind of β-interferon under the supervision of a neurologist in a period of no more than 30 days prior to the study.”

“At the onset of treatment all of the patients had an EDSS of less than 6.”

The eligibility criteria include patients with relapsing-remitting MS between ages 14-50, diagnosed based on clinical manifestations and MRI findings. Patients must accept the 24 month protocol. Some exclusions are made for safety reasons like pregnancy, but overall the criteria reflect typical MS patients who would receive interferon therapy in usual care.

Score: [4]

Recruitment

Quotes: None relevant

The paper does not describe how patients were recruited, so there is insufficient information to assess this domain.

Score: [NA]

Setting

Quotes:

“The study was a randomized clinical trial and included all the patients with MS referring to the Farshchian Hospital, Hamadan (West Iran) during the year 2005-2006”

The study was conducted at a single hospital center in Iran. The setting may not reflect the typical setting where interferon therapy is delivered and applied in other countries.

Score: [2]

Organization

Quotes: None relevant

The paper does not describe the expertise, resources, or organization of care delivery, so there is insufficient information to assess this domain.

Score: [NA]

Flexibility: delivery

Quotes:

“30 patients received Av (30 mcg IM on a weekly basis), 30 patients received Re (44 mcg SC three times a week) and 30 patients received Be (250 mcg SC on an alternate day basis).”

The interferon drugs were delivered according to fixed injection schedules without flexibility. This suggests an explanatory approach.

Score: [2]

Flexibility: adherence

Quotes: None relevant

The paper does not describe any measures to enforce or improve patient adherence, so there is insufficient information to assess this domain.

Score: [NA]

Follow-up

Quotes:

“The patients in all three groups were evaluated at the end of months 6, 12, 18, 24 and in case of development of reactions were excluded from the study.”

Patients were followed closely with evaluations every 6 months, more frequent than typical follow-up care. This suggests an explanatory approach.

Score: [2]

Primary outcome

Quotes:

“At the end of 24 months the patients were again evaluated for EDSS, and the number of relapses for each patient was calculated”

The primary outcomes of EDSS and relapse rate are clinically meaningful to patients.

Score: [4]

Primary analysis

Quotes: None relevant

The paper does not describe the primary analysis methods, so there is insufficient information to assess this domain.

Score: [NA]

Center-Based Group and Home-Based Individual Exercise Programs Have Similar Impacts on Gait and Balance in People With Multiple Sclerosis: A Randomized Trial (2021), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “697.pdf”:

Eligibility criteria

Quotes:

• “Inclusion criteria: diagnosis of MS made by a neurologist, able to walk 10 meters with or without an aid within 2 minutes, no relapse of their MS in the past 4 weeks, and no other neurological or orthopedic condition that would affect their function.”

• “Eligible participants were excluded from the study if they were already engaged in a formal exercise program lasting >30 minutes twice per week, experienced an exacerbation within the past 4 weeks, had their MS immunomodulation medications altered in the previous 4 weeks or during the trial period, or declined to be randomly allocated.”

Explanation: The eligibility criteria are moderately pragmatic. Patients had to have a confirmed diagnosis of MS and be able to walk at least 10 meters, which are reasonable criteria for a walking exercise intervention trial. However, excluding patients who were already exercising regularly, had a recent exacerbation or medication change, or declined randomization make the criteria less pragmatic. Overall, this domain seems moderately pragmatic but leaning towards the explanatory side. Score: [3]

Recruitment

Quotes:

• “Community dwelling people with MS were recruited through the Multiple Sclerosis Society of New South Wales and South Australia.”

Explanation: Recruitment was done through a MS society, which seems moderately pragmatic as people with MS who might be interested in an exercise program are members of such societies. However, recruiting only through a society may bias the sample compared to broad recruitment from clinical settings. There is not enough information to determine if any additional effort beyond contacting society members was made. Score: [3]

Setting

Quote:

• “The group program was conducted at a local community center and included four to six participants per class.”

Explanation: The setting was a local community center, which seems pragmatic as this matches real-world settings where group exercise classes are held. No mention is made of using specialized or academic centers. Score: [4]

Organization

Quote:

• “Groups were led by a physiotherapist employed by the Multiple Sclerosis Society who received training to ensure a standard approach to intervention, intensity, and progression.”

Explanation: A physiotherapist led the groups, which seems reasonably pragmatic, although the additional training to standardize the interventiondelivery across sites makes it slightly less so. No major changes like increased staffing or resources were mentioned. Score: [4]

Flexibility: delivery

Quote:

• “Guidelines were provided to physiotherapists and participants for exercises to be adapted and progressed to suit individual functional ability via increasing repetitions, amplitude of movement, speed of movement, and modifying base of support.”

Explanation: There was flexibility in how the exercises were delivered and progressed, tailored to each participant’s functional level. No strict protocol was described. Score: [4]

Flexibility: adherence

Quote:

• “In both group and home exercise sessions, participants completed eight, 6 minute exercises/stations per session plus a 5-minute warm up and cool down.”

Explanation: Participants were expected to complete the full exercise program, but no specific measures to enforce adherence were mentioned. This seems moderately pragmatic. Score: [3]

Follow-up

Quotes:

• “Outcome assessments were conducted at baseline, immediately post-intervention and at 8-week follow-up.”

• “Assessments were conducted by physiotherapists blinded to group allocation and trained in administering the outcome measures.”

Explanation: Follow-up was at two standard time points with blinded outcome assessment. No unscheduled or more frequent visits were mentioned. This seems pragmatic. Score: [4]

Primary outcome

Quote:

• “The primary outcome measure was gait speed, measured using the 10-meter walk test.”

Explanation: The primary outcome of gait speed is highly relevant and meaningful to patients. It was measured in a standard way that could be applied in real-world settings. Score: [5]

Primary analysis

Quote:

• “Data were analyzed according to the intention-to-treat principle.”

Explanation: An intention-to-treat analysis was used, which is the most pragmatic approach. No exclusions were mentioned. Score: [5]

Randomised natalizumab discontinuation study: taper protocol may prevent disease reactivation (2016), PragMS

Here are the PRECIS-2 scores for the 9 domains based on the full text in “696.pdf”:

Eligibility criteria:

Relevant quotes:

“Inclusion criteria consisted of: a diagnosis of relapsing MS according to McDonald criteria, being on natalizumab therapy for 24 months or longer, aged between 18 and 65 years and an EDSS score of ≤7.0.”

“Candidates were excluded from the study if active disease was identified at baseline per clinical ( presence of a relapse during the previous 30 days) and/or MRI evaluation (active gadolinium (Gd)-enhancing lesions).”

Reasoning: The inclusion criteria are quite broad, including all patients with relapsing MS who have been on natalizumab for at least 24 months. The main exclusion criteria are having a relapse in the past 30 days or active enhancing lesions on MRI. This is quite similar to eligibility in usual care.

Score: [4]

Recruitment:

Relevant quotes:

“Fifty patients with relapsing MS, followed at the Jacobs MS Center for Treatment and Research, Department of Neurology, University at Buffalo, Buffalo New York, USA, were enrolled in this study.”

Reasoning: Patients were recruited from a single specialized MS center, which is more explanatory than recruiting more broadly from multiple centers or clinics.

Score: [2]

Setting:

Relevant quotes:

“Fifty patients with relapsing MS, followed at the Jacobs MS Center for Treatment and Research, Department of Neurology, University at Buffalo, Buffalo New York, USA, were enrolled in this study.”

Reasoning: The trial was conducted at a single specialized MS center. This is more explanatory compared to a multi-center trial or centers more representative of usual care.

Score: [2]

Organisation:

Relevant quotes:

No relevant quotes.

Reasoning: The paper does not provide information about organization of care delivery. I cannot assess whether additional resources or training were used beyond usual care.

Score: [NA]

Flexibility (delivery):

Relevant quotes:

No relevant quotes.

Reasoning: The paper does not provide information about flexibility in delivering the intervention. I cannot assess if it matched usual care or was more standardized.

Score: [NA]

Flexibility (adherence):

Relevant quotes:

No relevant quotes.

Reasoning: The paper does not mention any measures to enforce adherence. But this was a trial of drug discontinuation, so adherence may not be applicable.

Score: [NA]

Follow-up:

Relevant quotes:

“Clinical assessments

A physical examination and neurological assessment was administered at baseline, 3, 6 and 12 months postdiscontinuation (counted from the last natalizumab infusion), as well as during unscheduled visits due to relapses (within 3–5 days of any new symptom development).”

Reasoning: Patients were followed regularly every 3 months, more frequently than in usual care. Additional unscheduled visits were triggered by relapses.

Score: [2]

Primary outcome:

Relevant quotes:

“Safety parameters evaluated as primary outcomes were defined as: (1) MRI parameters quantified by lesion activity analyses and changes in lesion volume (LV) and (2) clinical parameters that included the number of clinical relapses during the cessation period compared to the number of relapses before cessation in both the group as a whole as well as between the two randomised groups.”

Reasoning: The primary outcomes of MRI lesion activity and clinical relapses are directly relevant for patients.

Score: [5]

Primary analysis:

Relevant quotes:

No relevant quotes about primary analysis.

Reasoning: The paper does not provide information about the primary analysis. I cannot assess if it was intention-to-treat or restrictive.

Score: [NA]

Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO) (2018), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “694.pdf”:

Eligibility criteria

Quote: “MS patients older than 18 years who had a confirmed MS with spasticity of the lower limbs and an Expanded Disability Status Scale (EDSS) score between 4 and 6.5 were eligible for inclusion.”

The eligibility criteria are reasonably broad, including adult MS patients with confirmed diagnosis and spasticity in the lower limbs. The EDSS score requirement excludes those with very mild or very severe disability. This seems moderately pragmatic for a trial intending to assess impact on symptoms like balance and spasticity.

Score: [3]

Recruitment

Quote: “Eligible patients were randomized to one of the two groups using sealed opaque envelopes on the basis of a computer-generated randomization list.”

No details are provided on how patients were identified or approached for recruitment. This suggests typical clinic recruitment.

Score: [4]

Setting

Quote: “The study was conducted at five sites in Germany, all of which have hippotherapy experience as stipulated by the rules of the German Consortium for Therapeutic Riding.”

Conducting the trial across multiple sites suggests a pragmatic approach to ensure a varied patient population. The setting matches intended real-world usage.

Score: [4]

Organisation

Quote: “Patients of the intervention group received hippotherapy (as defined by the regulations for hippotherapy of the Deutsches Kuratorium für Therapeutisches Reiten e.V. (DKThR)) once a week for 12 weeks as an add-on therapy to their standard care, which remained unchanged.”

No mention of increased staffing, training, or resources. Hippotherapy was provided according to standard regulations. This suggests a pragmatic approach.

Score: [4]

Flexibility: delivery

Quote: “Hippotherapy (as defined by the regulations for hippotherapy of the Deutsches Kuratorium für Therapeutisches Reiten e.V. (DKThR))”

The hippotherapy intervention followed standard regulations, suggesting reasonable flexibility typical of real-world delivery.

Score: [4]

Flexibility: adherence

No relevant quotes. No mention of measures to enforce or monitor adherence.

Score: [NA]

Follow-up

Quote: “Examinations and questionnaires were completed prior to the first hippotherapy session (baseline), after 6–7 weeks (interim assessment) and after 12 weeks (final assessment).”

Follow-up schedule matches the intervention period with baseline, interim, and end assessment. This seems pragmatic.

Score: [4]

Primary outcome

Quote: “The primary endpoint was the change in the BBS (difference from BBS baseline to week 12).”

The BBS measures balance and risk of falls. This is a relevant primary outcome for MS patients.

Score: [4]

Primary analysis

Quote: “Analyses were based on the modified intention-to-treat set (modified ITT).”

Use of intention-to-treat analysis is a pragmatic approach.

Score: [5]

Influence of sports climbing and yoga on spasticity, cognitive function, mood and fatigue in patients with multiple sclerosis (2010), PragMS

Here are my assessments for the PRECIS-2 scores for the trial described in “693.pdf”:

Eligibility criteria:

Quotes:

“Inclusion criteria—Patients with confirmed diagnosis: ≥16 years of age with unilateral facial nerve weakness of no identifiable cause who presented to primary care or an emergency department and could be referred to a collaborating otorhinolaryngologist <72 hours after the onset of symptoms.”

“Exclusion criteria—Pregnancy, breast feeding, uncontrolled diabetes, peptic ulcer disease, suppurative otitis media, herpes zoster, multiple sclerosis, systematic infection, sarcoidosis and other rare conditions, and an inability to provide informed consent.”

“Randomised controlled trial of Bell’s palsy treatment required senior otorhinolaryngologist in hospitals to confirm a patient’s eligibility to participate. Bell’s palsy is usually diagnosed by a general practitioner in primary care.”

Reasoning: The inclusion criteria seem reasonably broad, including adults ≥16 years old with unilateral facial nerve weakness without identifiable cause. However, the exclusions eliminate some patients who would likely receive prednisolone or acyclovir treatment for Bell’s palsy in usual care, such as pregnant/breastfeeding women and those with certain medical conditions. Requiring confirmation by a specialist ORL rather than diagnosis by a GP makes the trial more explanatory.

Score: [2]

Recruitment:

Quotes: No relevant quotes about recruitment process.

Reasoning: No details provided on recruitment process.

Score: [NA]

Setting:

Quotes: No quotes on settings provided.

Reasoning: No details provided on settings of the trial.

Score: [NA]

Organisation:

Quotes: No relevant quotes about organization.

Reasoning: No details provided on organization of the trial.

Score: [NA]

Flexibility (delivery):

Quotes: No relevant quotes about flexibility of delivery.

Reasoning: No details provided on flexibility of delivery.

Score: [NA]

Flexibility (adherence):

Quotes: No relevant quotes about adherence.

Reasoning: No details provided on adherence or measures to enforce it.

Score: [NA]

Follow-up:

Quotes:

“Clinical follow-up until patient left hospital (discharge or death) or until 30 days after surgery, whichever was the longer, so more than usual care.”

“Monitoring intensity involved more extensive data collection than usual:

Pre-operation—three-lead electrocardiogram (ECG) Holter monitor (Flashcard with 2×48 hour recording) set up on each patient and maintained for 72 hours. Troponin values at 1, 3, and 7 days after surgery (more usual for only 1 and 3 days after surgery) ECG after randomisation and at 7 and 30 days after surgery.”

“Unscheduled follow-up visits triggered by primary outcome: a cardiovascular event (such as angina, myocardial infarction, stroke)”

Reasoning: Follow-up was more extensive than usual care, with more frequent visits, longer monitoring, and additional tests. Unscheduled visits were triggered by cardiovascular events.

Score: [1]

Primary outcome:

Quotes:

“Primary outcome—Recovery of facial function as rated on the House-Brackmann scale.”

“Test not routinely used in primary care and requires training. It is, however, an easy clinical test widely used in secondary care for grading recovery from facial nerve paralysis caused by damage to lower motor neurons.”

“Central adjudication—Photographs taken of patients were assessed and graded independently by a panel of three experts (not general practitioners, who usually assess).”

Reasoning: The House-Brackmann scale is not used routinely in primary care and required central adjudication by experts rather than assessment by GPs who usually diagnose Bell’s palsy. This makes the outcome less relevant to usual care.

Score: [1]

Primary analysis:

Quotes: No relevant quotes about analysis plan.

Reasoning: No details provided on analysis plan.

Score: [NA]

Improving Health of People With Multiple Sclerosis From a Multicenter Randomized Controlled Study in Parallel Groups: Preliminary Results on the Efficacy of a Mindfulness Intervention and Intention Implementation Associated With a Physical Activity Program (2021), PragMS

Here are the PRECIS-2 scores for the trial based on the publication:

Eligibility criteria:

Relevant quotes:

“Inclusion criteria for the study included (1) a diagnosis of MS, (2) not currently engaged in rehabilitation, therapy or PA program and able to undertake PA without risk-factors (3) aged between 18 and 65 (4) able to give informed consent and to understand French.”

Reasoning: The eligibility criteria are fairly inclusive, allowing adult MS patients with a range of disease severity and types to participate as long as they are not currently in a rehabilitation or PA program. Patients only needed to be able to undertake PA without risk factors, which is consistent with how PA would be recommended in clinical practice. The criteria do not appear to specifically select for patients expected to respond well to the intervention. The only major exclusion is due to language.

Score: [4]

Recruitment:

Relevant quotes:

“Individuals participating in either a combination of PA and daily Mindfulness or a combination of PA and Implementation Intention.”

“Participants were recruited from two hospitals in the Parisian region, in France receiving outpatient services for MS at a regional medical center.”

Reasoning: Participants were recruited directly from hospitals providing usual care for MS patients. No additional recruitment effort beyond approaching eligible patients at outpatient clinics is described. This matches how patients would be recruited for PA in routine practice.

Score: [5]

Setting:

Relevant quotes:

“This clinical and multicentric trial took place from July 2017 to January 2020, in two hospitals in the Parisian Region, France (Hospitals – CHI Poissy St Germain-en-Laye and R. Poincaré, Garches).”

Reasoning: The trial took place across two hospitals providing standard MS care. The setting aligns with where the intervention would be delivered in routine practice.

Score: [5]

Organization:

Relevant quotes:

“Practicing sessions were conducted under the supervision of a physical and sports activity trainer specializing in sports training.”

Reasoning: The PA program was delivered by a specialized trainer. No additional staffing or resources beyond having trained supervision are described. This matches typical organization of PA for MS patients.

Score: [4]

Flexibility (delivery):

Relevant quotes:

“Implementation Intention Participants were asked to develop a concrete if-then plan (the “if” component followed by the “then” component) once a week and share them through the TB application. These combinations were intended to decrease fatigue and improve mobility among people with MS.”

Reasoning: The implementation intention intervention allowed flexibility in the specific plans made week-to-week. The mindfulness intervention was also flexible in delivery through recorded sessions. Overall, the interventions could be individualized.

Score: [4]

Flexibility (adherence):

Relevant quotes:

No relevant quotes.

Reasoning: Adherence was not discussed. As an exercise intervention, this domain may not be as applicable.

Score: [NA]

Follow-up:

Relevant quotes:

“All measurements were carried out at two phases of the study T1 (baseline) and T2 (eight weeks after randomization).”

Reasoning: Follow-up matched the duration of the 8-week intervention with measures at baseline and end. This minimal follow-up is consistent with routine practice.

Score: [5]

Primary outcome:

Relevant quotes:

“Mobility, fatigue, and the impact of the disease on the patient’s life were measured by 6 min Walking Test (6MWT) (Guyatt et al., 1985) Modified Fatigue Impact Scale (MFIS) (Téllez et al., 2005), Health-related quality of life measured with EuroQoL (EQ5D-3L) (Goodwin et al., 2019) and Multiple Sclerosis Impact Scale (MSIS-29) (Hobart, 2001), respectively.”

Reasoning: The primary outcomes of mobility, fatigue, and quality of life are clinically meaningful to patients. The measures used are commonly applied in MS research.

Score: [5]

Primary analysis:

Relevant quotes:

No relevant quotes.

Reasoning: The analysis methods are not described in detail. With the small sample size, the use of non-parametric tests is appropriate. There is no indication participants were excluded.

Score: [4]

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis (2013), PragMS

Here are the PRECIS-2 domain scores and reasoning based on the full text in “691.pdf”:

Eligibility criteria

Quotes:

“The main inclusion criteria were: (1) clinically definite MS diagnosis, (2) fatigue impacting on daily life (Fatigue Severity Scale total score >4) and (3) ambulatory.”

“The main exclusion criteria were: (1) having taken part in a fatigue programme in the last year, (2) cognitive impairments, (3) a relapse in the previous 3 months or (4) having started treatment with disease modifying or antidepressant drugs within the previous 3 months.”

Reasoning: The eligibility criteria are fairly broad, including people with clinically definite MS diagnosis and significant fatigue impacting daily life. The main exclusions are to avoid contamination from recent participation in other fatigue programs or medication changes, and to avoid issues with assessing outcomes in those with cognitive impairments or recent relapses. Overall, the criteria seem aimed at a typical MS population with fatigue, rather than highly selective subgroups.

Score: [4]

Recruitment

Quotes:

“Participants were recruited in three UK centres (Poole, Bristol, Southampton/Portsmouth) from primary or secondary care, or via MS Society newsletters/websites.”

Reasoning: Participants were recruited through routine clinical settings and established MS information channels. No additional targeted efforts like advertising or incentives are mentioned. This matches usual recruitment for MS interventions.

Score: [4]

Setting

Quotes:

“Participants were recruited in three UK centres (Poole, Bristol, Southampton/Portsmouth) from primary or secondary care, or via MS Society newsletters/websites.”

Reasoning: The trial was conducted across 3 centers in the UK, including both primary and secondary care settings. This represents real-world variety in settings where MS fatigue interventions would be delivered.

Score: [5]

Organisation

Quotes:

“The FACETS intervention consists of six sessions (∼90 min duration) held weekly and facilitated in groups of 6–12 by two health professionals with experience of working with people with MS and group-work (such as occupational therapists, nurses or physiotherapists).”

“Facilitators were all qualified to a senior/advanced level (in the UK minimum of a Band 7 on the NHS Agenda for Change (AfC) grading structure).”

Reasoning: The intervention was delivered by existing healthcare professionals as part of their standard roles. The staffing and resource level seems typical for delivery of a group intervention in the NHS. No extra training, equipment, or resources were provided.

Score: [5]

Flexibility: delivery

Quotes:

“The facilitator manual provides guidance on preparation and delivery, detailed session content, notes and suggested timings, and a checklist of facilitator objectives as well as signposts to additional resources. Sessions are delivered via PowerPoint; hence can be easily replicated. A companion participant handbook, along with existing information booklets, reinforces programme content.”

Reasoning: The intervention is manualized with PowerPoint slides, handouts, and guidance for facilitators. This reduces flexibility in delivery compared to usual care. However, no measures to monitor or enforce compliance are mentioned.

Score: [3]

Flexibility: adherence

Quotes:

No discussion of measures to enforce adherence by participants.

Reasoning: There is no mention of monitoring or enforcing adherence by participants. Flexibility seems to match usual care.

Score: [5]

Follow-up

Quotes:

“Individuals who had attended a fatigue management programme in the past year were excluded from the trial as were those who had received a fatigue intervention from a health professional in the past 3 months (see protocol).”

“Outcomes were measured 1 week (baseline) before the start of FACETS and 1 month (follow-up 1) and 4 months (follow-up 2) after the final session.”

Reasoning: Follow-up is at 1 and 4 months post-intervention, with no unscheduled visits. This frequency seems reasonable and not excessive compared to usual care.

Score: [4]

Primary outcome

Quotes:

“These were: (1) fatigue severity (Global Fatigue Severity (GFS) subscale of the Fatigue Assessment Instrument (FAI)), (2) disease-specific quality of life (QOL) (total score on the Multiple Sclerosis Impact Scale, V.1 (MSIS-29, V.1)) and (3) self-efficacy for managing fatigue (Multiple Sclerosis-Fatigue Self-Efficacy scale—adapted from the Control subscale of the MS Self-Efficacy scale).”

Reasoning: The primary outcomes are patient-centered and clinically meaningful measures of fatigue, QOL, and self-efficacy. They do not appear to require special expertise to assess.

Score: [5]

Primary analysis

Quotes:

“The main analysis was intention-to-treat but we also conducted a ‘per protocol’ analysis (excluding participants who attended fewer than four FACETS sessions).”

Reasoning: The primary analysis was intention-to-treat, including all randomized participants. This matches a pragmatic approach.

Score: [5]

Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up (2018), PragMS

Here are the PRECIS-2 scores and explanations for the clinical trial described in the paper “Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up”:

Eligibility criteria

Relevant quotes:

“18e60 years of age, able to understand and comply with the study protocol, visual acuity with correction sufficient to work on a computer screen, clinically definite MS for at least 6 months and exacerbation free for 90 days…score ≥ 10 [on the Perceived Deficits Questionnaire], indicating some problems in at least 5 areas”

The eligibility criteria are moderately broad - the age range covers adults of working age, and excludes only those with very recent MS diagnoses or exacerbations. The Perceived Deficits Questionnaire screens for self-reported cognitive difficulties. Overall, the criteria aim to recruit typical MS patients with cognitive complaints, not just an ideal adherent sample.

Score: [3]

Recruitment

Relevant quotes:

“Participants were recruited via physician referral, targeted mailings to persons with MS on the mailing list of the National MS Society, contact with support groups, and notices in MS newsletters and web sites.”

Recruitment utilized typical methods like physician referral and contacting MS support groups. No excessive incentives or advertising campaigns were mentioned. This matches routine patient recruitment.

Score: [4]

Setting

Relevant quotes:

“Following approval by the Institutional Review Board for the University of Texas at Austin, participants were recruited from three large metropolitan communities in Texas: Houston, San Antonio and Dallas.”

The trial was conducted across multiple sites in diverse metropolitan areas, indicating a pragmatic setting.

Score: [4]

Organisation

Relevant quotes:

No relevant quotes.

The paper does not mention extensive additional staffing, training, or resources beyond routine care.

Score: [4]

Flexibility: Delivery

Relevant quotes:

No relevant quotes.

The computer training protocol is specified but allows flexibility in delivery. No further protocol details are provided.

Score: [4]

Flexibility: Adherence

Relevant quotes:

“The facilitator prescribed exercises from a study-specific protocol addressing the most common deficits experienced by persons with MS (attention, memory, flexibility, and problem solving). The games/tasks (see Table 1) were arranged so that the most basic cognitive skills (attention) were addressed first.”

Adherence was encouraged but not tightly monitored or enforced. This matches routine practice.

Score: [4]

Follow-up

Relevant quotes:

“Neuropsychological testing and questionnaire data were collected from all subjects at baseline, following completion of the 8-week MAPPS intervention, and 3 and 6 months post-intervention.”

Follow-up data collection was at limited time points over 6 months. No excessive visits or monitoring is mentioned.

Score: [4]

Primary outcome

Relevant quotes:

“The primary purpose of this study was to determine the effectiveness of a novel computer-assisted cognitive rehabilitation intervention MAPSS-MS (Memory, Attention, Problem Solving Skills in MS) in a multi-site trial with persons with MS.”

“The 70-min battery included the following widely used tests: the Controlled Oral Word Association Test (COWAT) - verbal fluency and word finding; The California Verbal Learning Test, 2nd ed, (CVLT-II) - verbal learning and remembering; The Brief Visuospatial Memory Test e Revised (BVMT-R) - nonverbal learning and memory; The Paced Auditory Serial Addition Test (PASAT) - auditory information processing speed and flexibility, as well as calculation abilities; and The Symbol Digit Modalities Test (SDMT) - complex scanning and visual tracking.”

The primary outcome was cognitive performance on clinically relevant neuropsychological tests.

Score: [5]

Primary analysis

Relevant quotes:

“Data analyses were conducted using SPSS, version 24.0 for Windows (SPSS Inc., Chicago, IL, USA). Neuropsychological data were scored by the testers and verified by a second staff member. Data were entered and checked for accuracy.”

“For the current study, we employed intention-to-treat strategies to handle missing data using a “last observation carried forward” (LOCF) strategy in which missing data points are imputed based on the participant’s existing data.”

An intention-to-treat analysis was used with all available data.

Score: [5]

Combining a supervised and home-based task-oriented circuit training improves walking endurance in patients with multiple sclerosis. The MS_TOCT randomized-controlled trial (2022), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in the paper “1569.pdf”:

Eligibility criteria

Relevant quotes:

“The inclusion criteria were: males and females; age 18 to 70; diagnosis of MS (primary or secondary progressive, relapsing-remitting), without relapses in the preceding three months and an Expanded Disability Status Scale (EDSS) score between 4 and 5.5. This criteria reflects the inclusion of PwMS with an unassisted but limited walking competency (100–500 m).”

The inclusion criteria target patients with MS who have moderate disability but are still ambulatory. The EDSS 4-5.5 range selects those with limited walking ability. The criteria seem reasonably aligned with patients who would receive this intervention in usual clinical care.

Score: [4]

Recruitment

Relevant quotes:

“Patients have been recruited at Ferrara University Hospital from patients who attend the Rehabilitation Outpatient Clinic for gait rehabilitation. They signed informed consent before any evaluation or treatment.”

Patients were recruited from a rehabilitation clinic where they were already receiving care for gait issues. This pragmatic recruitment approach mirrors how patients would access this intervention in usual care.

Score: [5]

Setting

Relevant quotes:

“Patients have been recruited at Ferrara University Hospital from patients who attend the Rehabilitation Outpatient Clinic for gait rehabilitation.”

The trial was conducted at a single hospital rehabilitation clinic. While a multi-center trial would be more pragmatic, this setting aligns with usual care for gait rehabilitation in MS patients.

Score: [4]

Organization

Relevant quotes:

No relevant quotes. The paper does not mention any differences in staffing, training, or resources compared to usual care.

The organization of care delivery seems unchanged from what patients would receive in usual gait rehabilitation.

Score: [5]

Flexibility: delivery

Relevant quotes:

“TOCT includes six workstations with five levels of complexity (step, slalom, tandem exercise, goals, obstacles, long step). PwMS exercised for 5 min in each one (3 min of activities and 2 min of rest). A full description of exercise protocol is available elsewhere. They underwent two laps during each session that take about 60 min (6 workstations x 5 min x 2 laps), with 10 min of rest after each lap.”

The supervised TOCT protocol is highly structured with prescribed stations, exercise duration, and rest periods. This reduces flexibility in intervention delivery.

Score: [2]

Flexibility: adherence

Relevant quotes:

No relevant quotes. The paper does not mention any measures to enforce or monitor adherence.

There seems to be no less flexibility than in usual care for how patients adhere to the intervention.

Score: [5]

Follow-up

Relevant quotes:

“The blind evaluator, who did not supervise the training program, performed functional tests, questionnaires and instrumental measurements the week before treatment, the week after the end of the supervised-TOCT, after the 12-weeks home-based TOCT program.”

Follow-up intensity mirrors what would occur in usual care, with assessment at baseline, after the supervised portion, and after the full program.

Score: [4]

Primary outcome

Relevant quotes:

“The primary outcome measure was the 6-minute walking test (6MWT) for walking endurance.”

The 6MWT is a direct measure of walking ability and clinically important to patients.

Score: [5]

Primary analysis

Relevant quotes:

No relevant quotes, but the paper states “An intention-to-treat analysis was carried out on all outcome measures”

The intention-to-treat approach is pragmatic and includes all randomized participants.

Score: [5]

Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis (2018), PragMS

Here are the PRECIS-2 domain scores and justifications based on the provided full text:

Eligibility criteria

Relevant quotes:

“Participants were non-institutionalized adults (age ≥ 18 years) with severe MS and their primary carers.”

“Other patient inclusion criteria were primary or secondary progressive MS, [1,13] Expanded Disability Status Scale (EDSS) score ≥ 8.0, [14] complex symptoms, [15] and ≥2 unmet care needs.”

“All patient-carer dyads gave written informed consent before study enrollment.”

Score: [4] Rather pragmatic

The eligibility criteria target the intended population for the intervention (severe MS patients and their caregivers) using criteria commonly used in MS research like EDSS score and type of MS. While restrictive, the criteria seem aligned with identifying patients who would need and receive this intervention in usual care. The inclusion of caregivers also matches usual care. The consent requirement is standard.

Recruitment

Relevant quotes:

“Dyads were randomly assigned (2:1) to receive HPA or UC. Allocation to treatment groups was done using a third-party, web-based computerized randomization procedure with stratified minimization for EDSS score (8.0–8.5, 9.0–9.5), presence of severe cognitive compromise (clinical judgment), and center”

Score: [3] Equally pragmatic and explanatory

The recruitment through minimization randomization is more explanatory, since it tries to balance groups on selected factors. However, recruitment is from patients already engaged with the participating clinical centers, which is more pragmatic. Overall, recruitment has explanatory and pragmatic elements.

Setting

Relevant quotes:

“In this randomized, examiner-blind, controlled study, we recruited patients from three Italian centers.”

Score: [3] Equally pragmatic and explanatory

Conducting the trial across 3 centers makes it more pragmatic and enhances generalizability. However, limiting to only 3 centers in Italy without further description makes it unclear how well the settings match real-world care settings. The setting has both pragmatic and explanatory elements.

Organization

Relevant quotes:

“Based on the principles of PC, each center had a HPA team consisting of a physician (neurologist or physiatrist), a nurse (case manager and team leader), a psychologist, and a social worker.”

“The nurse (team leader) performed 152 visits (33%), followed by the psychologist (25%), the physician (25%), and the social worker (17%).”

Score: [2] Rather explanatory

The HPA team brings additional expertise and resources beyond usual care for MS patients. The involvement of multiple specialists for home visits is not reflective of typical care. The organization is skewed toward being more explanatory.

Flexibility: Delivery

Relevant quotes:

“After a comprehensive assessment of the dyad needs based on direct observation and on visit 1 information (available via the eCRF), the HPA team defined the contents of the intervention, involving the dyad and the patient caring physician (the intervention was not intended to replace existing services).”

Score: [3] Equally pragmatic and explanatory

The delivery allows for some flexibility in tailoring to each dyad’s needs, which is more pragmatic. However, it is protocolized with comprehensive assessment and eCRF documentation. The delivery has explanatory and pragmatic aspects.

Flexibility: Adherence

Relevant quotes:

No relevant quotes.

Score: [NA]

The text does not provide enough information to assess flexibility of adherence.

Follow-up

Relevant quotes:

“All team activities were recorded in the PeNSAMI patient study record, which was kept at the patient’s home and available to all HPs/caregivers.”

“Dyads assigned to UC received the three examiner visits (visits 1–3) and the monthly telephone interviews, but not the HPA team visits (except visit 0).”

Score: [2] Rather explanatory

The HPA team visits and detailed documentation in study records constitute more intensive follow-up than usual care. The additional examiner visits and monthly calls for the UC group also make follow-up more explanatory.

Primary Outcome

Relevant quotes:

“The pre-specified primary endpoints were changes in patient quality of life (SEIQoL-DW) and symptom burden (PC Outcome Scale-Symptoms-MS, POS-S-MS).”

Score: [4] Rather pragmatic

The quality of life and symptom measures seem patient-centered and relevant for evaluating a palliative care intervention. The outcomes are meaningful for patients.

Primary Analysis

Relevant quotes:

“All randomly assigned patients were included in the main intention-to-treat analysis, provided that at least one contact with the team occurred (HPA group).”

Score: [5] Very pragmatic

The analysis used an intention-to-treat approach including all randomized patients with at least one contact. This data analysis matches usual care and is very pragmatic.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial (2019), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “689.pdf”:

Eligibility criteria

Quotes:

• “Potential participants known to Multiple Sclerosis healthcare practitioners working across seven outpatient centres in Scotland – Ayrshire & Arran, Greater Glasgow & Clyde, Dumfries and Galloway, Lanarkshire, Lothian, Fife and Tayside – were informed of the study and issued with a participant information sheet.”

• “Participants required to have a clinical diagnosis of Multiple Sclerosis, persistent foot drop (lasting a minimum of three months) observed during a 5-minute walk test, stable disease (no change in the Extended Disability Status Score12 or relapse in previous three months), 5° of passive dorsiflexion and tolerance of functional electrical stimulation.”

• “Participants were excluded if they had previously used functional electrical stimulation or an ankle-foot orthosis for foot drop, moderate to severe cognitive impairment (scored < 26, Montreal Cognitive Assessment),13 foot drop due to other disorders, other conditions significantly affecting gait, contraindications to functional electrical stimulation, marked proximal weakness, plantar flexor spasticity, stance phase instability or severe lower limb/trunk ataxia affecting gait.”

The eligibility criteria are relatively broad, including adults with MS and persistent foot drop. The main exclusions are previous use of assistive devices for foot drop and conditions that would significantly impact the effects of the interventions. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Quotes:

• “Potential participants known to Multiple Sclerosis healthcare practitioners working across seven outpatient centres in Scotland – Ayrshire & Arran, Greater Glasgow & Clyde, Dumfries and Galloway, Lanarkshire, Lothian, Fife and Tayside – were informed of the study and issued with a participant information sheet. Potential participants contacted the researchers if they were interested in participating.”

Recruitment was done through healthcare practitioners at MS clinics informing potential participants. Patients then had to contact the researchers directly if interested. This seems moderately pragmatic as patients were identified through usual care clinics, but some extra effort was required for them to contact the researchers.

Score: [3]

Setting

Quotes:

• “Potential participants known to Multiple Sclerosis healthcare practitioners working across seven outpatient centres in Scotland – Ayrshire & Arran, Greater Glasgow & Clyde, Dumfries and Galloway, Lanarkshire, Lothian, Fife and Tayside – were informed of the study and issued with a participant information sheet.”

The study was conducted across 7 MS outpatient clinics in Scotland. This multicenter design across usual care settings is pragmatic.

Score: [4]

Organization

Quotes:

• “Participants randomized to the usual care group were fitted with a custom-made, solid, ankle-foot orthosis by an orthotist, within four weeks of their initial assessment.”

• “Participants randomized to the functional electrical stimulation group were assessed and fitted with an Odstock Dropped Foot Stimulator Pace (OML, Salisbury) device by a physiotherapist experienced in functional electrical stimulation (A.L.).”

The AFOs were provided by orthotists and FES devices were fitted by physiotherapists, which reflects usual expertise. No mention of extra resources or training. Seems moderately pragmatic.

Score: [3]

Flexibility: Delivery

Quotes:

• “The angle of the tibia was inclined forward, approximately 10° to vertical, and each orthosis was ‘tuned’ by the addition or removal of small heel wedges.”

• “Wired heel switches and a stimulation frequency of 40 Hz were applied. Electrode position, pulse width, waveform and ramping parameters were adjusted for each participant in order to achieve a comfortable and efficient muscle contraction. The current amplitude ranged from 7 to 72 mA (mean = 40 mA).”

The AFOs were customized and tuned for each participant. The FES devices were also customized by adjusting parameters to optimize response. There was flexibility in delivery for both interventions.

Score: [4]

Flexibility: Adherence

No relevant quotes. There is no mention of measures to enforce adherence. Seems pragmatic but insufficient information.

Score: [NA]

Follow-up

Quotes:

• “Outcome measures were administered by two unblinded assessors (Rebecca Hunter and A.L.) at baseline (0), 3, 6 and 12 months”

• “Against a background of financial constraints, there is a need for evidence of the cost benefits of interventions. Our study indicates that although the upfront costs of functional electrical stimulation are greater than usual care (ankle-foot orthoses), it may be considered as a potentially cost-effective treatment option for foot drop and offers a value for money alternative in Multiple Sclerosis.”

Follow-up assessments were done at baseline, 3, 6, and 12 months. This frequency seems moderately pragmatic. Cost data was also collected which may be more intensive than usual care.

Score: [3]

Primary outcome

Quotes:

• “The primary aim of our study was to compare the clinical- and cost-effectiveness of ankle-foot orthoses and functional electrical stimulation over 12 months in people with Multiple Sclerosis presenting with foot drop.”

• “The primary outcome was walking speed as measured by the 5-minute self-selected walk test.”

The primary outcome of walking speed is highly relevant and meaningful to patients with MS and foot drop.

Score: [5]

Primary analysis

Quote:

• “A Restricted Maximum Likelihood approach to fitting mixed models was employed to allow intention to treat assumptions to cope with missing data.”

An intention-to-treat approach was used which is pragmatic.

Score: [4]

Web-based physiotherapy for people moderately affected with Multiple Sclerosis; quantitative and qualitative data from a randomized, controlled pilot study (2014), PragMS

Here are the PRECIS-2 scores for the clinical trial described in the attached paper “687.pdf”:

Eligibility criteria

Relevant quotes:

“To be included in the study participants were required to have a confirmed diagnosis of MS, an Expanded Disability Status Score of between 5 and 6.5, stable drug therapy for 30 days, no relapses in the previous three months, no significant co-morbidities such as coexisting cardiac or pulmonary condition and have access to the internet via personal or tablet computer.”

“Letters were sent to 138 patients from the Multiple Sclerosis Service database, thought to be suitable for the study, inviting them to participate. Of those 37 people expressed an interest in taking part. Seven people were excluded as they did not meet the inclusion and exclusion criteria (Figure 1).”

The eligibility criteria are moderately pragmatic. The inclusion criteria target a specific population of MS patients with moderate disability based on the EDSS score. The exclusion criteria rule out patients with co-morbidities, recent relapses, and medication changes, which improves internal validity but reduces generalizability. However, the criteria overall are not highly restrictive and the participant population likely resembles the target population in usual care settings.

Score: [3]

Recruitment

Relevant quotes:

“Letters were sent to 138 patients from the Multiple Sclerosis Service database, thought to be suitable for the study, inviting them to participate.”

“Of those 37 people expressed an interest in taking part.”

The recruitment method involved screening a disease-specific database and mailing invitation letters, which requires some extra effort beyond usual care. However, patients were not recruited through advertising or other non-standard routes. Overall, the recruitment is moderately pragmatic.

Score: [3]

Setting

Relevant quotes:

“Participants were recruited from the Multiple Sclerosis Service, at the Douglas Grant Rehabilitation Centre, Irvine, Scotland.”

The setting is a single specialized rehabilitation center, which may not reflect the full range of usual care settings. This reduces the generalizability of the results.

Score: [2]

Organization

Relevant quotes:

No relevant quotes found. The paper does not mention additional staffing, training, resources, or other changes to care delivery for the intervention.

The organization appears similar to usual care, but details are not provided.

Score: [NA]

Flexibility (delivery)

Relevant quotes:

“Individualised therapeutic exercise programmes were developed for participants in Group 1, with exercises selected based on their baseline assessment and personal goals.”

“Participants were advised to undertake the exercise programme a minimum of twice a week and to complete their online exercise diary which was seen remotely by the physiotherapist.”

The delivery allows for individualized programs tailored to each participant’s goals and baseline assessment. Participants had flexibility in how often they performed the exercises. The physiotherapist monitored progress through the online diaries but there is no mention of strict protocols or measures to improve compliance. The flexibility seems moderately pragmatic.

Score: [3]

Flexibility (adherence)

Relevant quotes:

No relevant quotes found. The paper does not mention any measures to enforce or monitor adherence.

There appears to be full flexibility for participants to adhere as they want, which is very pragmatic. However, details are limited.

Score: [NA]

Follow-up

Relevant quotes:

“Outcome measures were recorded at baseline and at the end of the intervention period (week 13).”

The follow-up consists only of outcome assessments at baseline and study end, with no additional contacts or data collection. This is very pragmatic.

Score: [5]

Primary outcome

Relevant quotes:

“The primary outcome measure, the timed 25 foot walk, has good reliability and validity in the MS population. The time taken to walk 25ft was recorded with a stop watch and a mean of two ‘walks’ recorded.”

The primary outcome is gait speed measured by the 25 foot walk test. This is a clinically meaningful outcome that directly evaluates walking ability, which is relevant to MS patients. The assessment does not require specialized expertise. Overall, this is a pragmatic choice of primary outcome.

Score: [4]

Primary analysis

Relevant quotes:

No relevant quotes found. The paper does not provide details on the primary analysis method.

There is insufficient information to assess the primary analysis.

Score: [NA]

In summary, this pilot RCT of web-based physiotherapy for MS patients has moderately pragmatic design choices for eligibility criteria, recruitment, setting, delivery flexibility, and primary outcome. Follow-up is very pragmatic with outcome assessments only at baseline and study end. Details are lacking for organization, adherence flexibility, and primary analysis. Based on the available information, the trial overall seems to have a moderately pragmatic approach.

Evaluation of an integrated multidisciplinary approach in multiple sclerosis care: A prospective, randomized, controlled study (2015), PragMS

Here are the PRECIS-2 scores for the trial described in the attached full text “686.pdf”:

Eligibility criteria

Relevant quotes:

• “Inclusion criteria were: having MS (MacDonald criteria); being able to complete a questionnaire; and being in need for a multi-disciplinary approach, defined by the requirement, in addition to the neurology specialist, of at least two different medical (rehabilitation specialist, neuro-urology specialist, psychiatrist) or allied health professionals (physiotherapist, occupational therapist, social worker, psychologist, and neuropsychologist).”

• “Patients who were not living independently in the community were excluded.”

The inclusion criteria are quite broad, including any MS patients in need of multidisciplinary care. The only exclusion criterion is for patients not living independently in the community. This is pragmatic as it matches usual care where interventions would likely not be provided for institutionalized patients.

Score: [4]

Recruitment

Relevant quotes:

• No details provided on how patients were recruited.

There are no details provided on how patients were recruited into the trial.

Score: [NA]

Setting

Relevant quotes:

• “This is a prospective, randomized, controlled, monocentric clinical trial in MS patients.”

• “MS patients from the outpatient clinic of the Neurology Department of Pitie ́-Salpeˆtrie`re Hospital were prospectively enrolled in the study between March 2010 and July 2012.”

The trial was conducted at a single hospital center. This reduces generalizability of the results to other settings.

Score: [2]

Organisation

Relevant quotes:

• “For patients in the IMD group, the multidisciplinary integrated outpatient clinic was planned at our MS clinic within a max-imum three-month period after inclusion. These patients received a half-day (four to six hours) indi-vidually tailored assessment by the multidisciplinary group.”

• “In the control group, interventions with the different health professionals were planned after the inclusion visit, with an explanatory letter given to the patient or directly sent to the professionals.”

• “In most cases the same health professionals were in charge of the two groups.”

The organization of care delivery appears similar between the two arms - the same health professionals took care of patients in both groups. The only difference is the integrated format for the intervention arm.

Score: [4]

Flexibility: delivery

Relevant quotes:

• No details provided on flexibility in delivering the intervention.

There are no details provided on flexibility in how the intervention was delivered.

Score: [NA]

Flexibility: adherence

Relevant quotes:

• No details provided on measures for adherence.

There are no details provided on measures to ensure adherence to the intervention.

Score: [NA]

Follow-up

Relevant quotes:

• “Primary and secondary outcomes were assessed at inclusion, and after six (M6) and 12 (M12) months.”

Patients were followed up at 6 and 12 months to assess outcomes. This does not seem much different from usual follow-up care.

Score: [4]

Primary outcome

Relevant quotes:

• “The primary outcome was the impact of the strategy on quality of life (QoL) measured using the MSIS-29 scale at inclusion and after six months.”

The primary outcome is quality of life measured by MSIS-29 scale. This is a patient-centered outcome that is clinically meaningful.

Score: [5]

Primary analysis

Relevant quotes:

• No details provided on primary analysis.

There are no details provided on the primary analysis.

Score: [NA]

Participation in and outcomes from a 12-month tailored exercise programme for people with multiple sclerosis (MSTEP�): a randomized trial (2020), PragMS

Here are the PRECIS-2 scores for the trial based on the full text publication:

Eligibility criteria

Relevant quotes:

“Inclusion criteria were (1) ambulatory (can walk 100 m, be capable of walking 100 metres without a walking aid corresponding to a classification of ≤5.5 on the Expanded Disability Status Scale (EDSS),10 even if they do use an aid for daily activities); and (2) self-reported to be sedentary or irregularly active at time of study entry (i.e. do not exercise 30 minutes or more twice per week of moderate to vigorous activity).”

“Excluded were people who were (1) unable to speak and read English or French; (2) unable to respond to simple questions on orientation and memory; (3) have an additional illness that restricts their function; and/or (4) experienced a relapse during the past 30 days as this may affect physical activity/exercise participation.”

Reasoning: The inclusion criteria targeted ambulatory individuals with relapsing-remitting MS who were sedentary. The exclusion criteria were minimal and would not exclude individuals who would normally receive the intervention in usual care. Overall, the eligibility criteria were broadly inclusive to match usual care.

Score: [4]

Recruitment

Relevant quotes:

“People were recruited from four multiple sclerosis clinics in three Canadian cities and from posting on media sites.”

“During the clinic visit, the treating neurologist introduced the study to their patients and referred them to the research assistant who further explained the study and assessed eligibility. Those contacting the research team directly were assessed for eligibility over the phone and sent information on the study electronically.”

Reasoning: Participants were recruited through usual clinic visits and referrals from treating neurologists. Additional recruitment was done through media advertising to supplement clinic recruitment. Overall, recruitment included routine clinical encounters but required some extra effort beyond typical care.

Score: [3]

Setting

Relevant quotes:

“The trial received ethical approval from the Montreal Neurological Hospital Research Ethics Board (NEU-12-005) and the Health Research Ethics Board, University of Manitoba (H2014:226)”

“People were recruited from four multiple sclerosis clinics in three Canadian cities and from posting on media sites.”

Reasoning: The trial was conducted across multiple hospitals and clinics in Canada. This matches the typical real-world settings where people with MS receive care.

Score: [5]

Organization

Relevant quotes:

“Participants in both groups received two private training sessions with the physical therapist or exercise therapist. For the MSTEP© group, the sessions were used to assess individual needs and design an individualized programme. For the Guideline group, the sessions were used to instruct on the guidelines and learn how to apply principles of safe and effective exercise. All were provided with a portfolio of exercise instructions.”

Reasoning: Both groups received some additional training and resources beyond what would be typical in usual care. However, the training was limited to 2 sessions and focused on instructing participants on the exercise regimen. No major changes were made to expertise of providers or care delivery resources.

Score: [4]

Flexibility: delivery

Relevant quotes:

“All had their exercise regimens reviewed during the intervention year at the evaluations which were scheduled at 3, 6, and 12 months.”

“The MSTEP© programme is to promote regular bouts of activity most days per week, encouraging a balance between rest and activity, and taking into consideration the physical and emotional status and capacity of the person.”

Reasoning: The MSTEP program was individualized and flexible based on the needs and capacities of each participant. Participants met with providers periodically to review their programs, but there was no strict protocol dictating exercise schedule or delivery. Flexibility appears very similar to usual care.

Score: [5]

Flexibility: adherence

Relevant quotes:

No relevant quotes.

Reasoning: There is no mention of specific measures to enforce or monitor adherence. The paper notes the high dropout rate, suggesting adherence was not enforced. This matches the flexibility expected in usual care.

Score: [5]

Follow-up

Relevant quotes:

“All had their exercise regimens reviewed during the intervention year at the evaluations which were scheduled at 3, 6, and 12 months.”

Reasoning: Follow-up visits occurred at 3, 6 and 12 months to review the exercise regimens. This frequency of follow-up is more than would occur in usual care.

Score: [3]

Primary outcome

Relevant quotes:

“The primary outcome was exercise capacity as measured by peak oxygen consumption (VO2peak) using a modified Bruce protocol on the cycle ergometer.”

Reasoning: VO2peak is a direct measure of exercise capacity and is clinically relevant to participants with MS who experience fatigue and deconditioning. This matches the importance of outcomes in usual care.

Score: [5]

Primary analysis

Relevant quotes:

“The intention was to follow participants for the first year of the intervention when the exercise programme was designed and adjusted as needed and have a further follow-up after the second year. As there were substantial losses to follow-up, only results after one year are presented.”

Reasoning: The study used an intention-to-treat analysis for all randomized participants. This matches the analysis approach expected in usual care.

Score: [5]

The effects of a 12-week leisure centre-based, group exercise intervention for people moderately affected with multiple sclerosis: a randomized controlled pilot study (2012), PragMS

Here are the PRECIS-2 scores for the trial described in “681.pdf”:

Eligibility criteria

Quotes:

“Participants had a confirmed diagnosis of multiple sclerosis, an Extended Disability Status Scale score of 5 (ambulatory without aid or rest for about 200 m) to 6.5 (constant bilateral assistance required to walk about 20 m without resting), stable rehabilitation and drug therapy for 30 days before entry into the study, cognitive scores of over 24 on the Mini-Mental State Examination and access to the intervention sites using their own or public transport.”

“Potential participants were excluded if they had experienced exacerbation of their multiple sclerosis symptoms three months prior to the study, or had any medical condition which may preclude them from taking part in the exercise intervention.”

The eligibility criteria are reasonably inclusive, allowing a range of disability levels and only excluding those with very recent exacerbations or other medical conditions that would prevent exercise. The confirmed MS diagnosis and cognitive screening are pragmatic given the nature of the intervention. Overall, the criteria seem intended to get a representative sample of the target population.

Score: [4]

Recruitment

Quotes:

“Potential participants (n 1⁄4 159) were sent invitation letters and participant information sheets.”

“Thus 36 people were invited for screening.”

Recruitment was done by contacting potential participants from a clinical register and inviting them to participate. There was no mention of advertising or other special efforts beyond invitation letters. This seems like a reasonably pragmatic approach.

Score: [4]

Setting

Quotes:

“The intervention took place at two different geographical locations (Site A and Site B).”

“From those living near Site A a list of potential participants (n 1⁄4 16) was created and, to maximise class occupancy, 10 potential participants were allocated to Site A’s intervention group. A similar system was used for Site B (which had a class capacity of 12), for which a list of potential participants (n 1⁄4 20) was created.”

The classes took place in two community leisure centers, which seems like a very pragmatic setting for an exercise intervention intended for community implementation.

Score: [5]

Organization

Quotes:

“Each group was led by two instructors (one physiotherapist and one fitness instructor).”

“The same physiotherapist was present at both sites; however fitness instructors were different between sites.”

The classes were led by a physiotherapist and fitness instructor, which seems like a reasonably pragmatic level of expertise for delivering an exercise intervention in the community. There is no mention of additional resources or training beyond what would be typical.

Score: [4]

Flexibility: delivery

Quotes:

“Through discussion with the instructors, participants chose which level of each exercise they deemed appropriate and also when and how each exercise should be progressed.”

“Participants worked at a self-regulated pace for each exercise.”

The delivery of the exercises seems very flexible, with participants able to choose intensity levels and progression. This was self-paced and individualized.

Score: [5]

Flexibility: adherence

Quotes:

No relevant quotes found.

The paper does not mention any specific strategies to enforce or monitor adherence. Attendance was tracked but there is no indication that participants were excluded or penalized for non-adherence.

Score: [4]

Follow-up

Quotes:

“Outcome measures were carried out within the local hospital’s rehabilitation unit. They were taken at baseline, after 8 and 12 weeks of the intervention period (i.e. either the exercise class or usual care).”

Follow-up assessments were done at baseline, 8 weeks, and 12 weeks. The assessments required scheduled visits but were not overly frequent.

Score: [4]

Primary outcome

Quotes:

“The Timed 25-Foot Walk Test measures walking speed over a short distance and has shown good reliability and validity in the multiple sclerosis population as an individual component of the Multiple Sclerosis Functional Composite disability assessment.”

The primary outcome was walking speed, which is a meaningful functional measure for MS patients. It does not seem to require special expertise or adjudication.

Score: [4]

Primary analysis

Quotes:

“All outcome measures were analysed on the basis of intention to treat, with all variables summarized and comparisons made between groups and over time.”

The analysis was based on intention-to-treat, which is a pragmatic approach.

Score: [5]

Efficacy of high-intensity aerobic exercise on cognitive performance in people with multiple sclerosis: A randomized controlled trial (2021), PragMS

Here are the PRECIS-2 scores and explanations for the trial based on the full text:

Eligibility criteria

Quotes:

• “For inclusion and exclusion criteria, see Langeskov-Christensen et al24”

• “At inclusion, a neurologist examined participants to determine the Expanded Disability Status Scale (EDSS) score, unless a recent score (<6 months) followed by a disease stable period existed.”

Reasoning: The eligibility criteria seem fairly broad, including people with any MS subtype as long as they have a recent stable EDSS score. The only major exclusions seem to be significant comorbidities and inability to exercise. This matches usual care pretty closely.

Score: [4]

Recruitment

Quotes:

• “Eighty-six participants were recruited from Danish MS clinics (Aarhus University Hospital, Viborg Regional Hospital, Odense University Hospital, and the MS Clinic of Southern Jutland (Kolding)).”

Reasoning: Participants were recruited when they attended standard clinic appointments at multiple centers. No extra efforts like advertising seem to have been used. This matches usual care.

Score: [5]

Setting

Quotes:

• “Eighty-six participants were recruited from Danish MS clinics (Aarhus University Hospital, Viborg Regional Hospital, Odense University Hospital, and the MS Clinic of Southern Jutland (Kolding)).”

Reasoning: The trial was conducted at standard MS clinics where patients receive usual care. No specialized or single-center settings were used.

Score: [5]

Organization

Quotes:

• “Supervised PAE sessions were conducted twice weekly during the 24 weeks, with one continuous and one interval exercise session performed each week.”

Reasoning: The intervention was delivered by study staff during supervised sessions twice per week. This provides more resources and monitoring than would occur in usual care.

Score: [2]

Flexibility: Delivery

Quotes:

• “In brief, the session volume increased from 30 to 60 minutes during the intervention while the intensity increased from 65% to 95% of individual maximum heart rate (HRmax).”

• “For further details on exercise modality options and the progressing volume and intensity of the exercise sessions, see Langeskov-Christensen et al.23”

Reasoning: The exercise intervention followed a standardized protocol with set progression of duration and intensity. This leaves little flexibility in how it is delivered compared to usual care.

Score: [2]

Flexibility: Adherence

Quotes:

• No discussion of measures to enforce adherence

Reasoning: There is no mention of monitoring or enforcing patient adherence to the exercise program. This matches the flexibility expected in usual care.

Score: [5]

Follow-up

Quotes:

• “At baseline (T0), after 24 (T24) and after 48 (T48) weeks, participants performed the BRB-N, the Major Depression Inventory (MDI), and a cardiorespiratory fitness test (VO2-max test).”

Reasoning: Follow-up assessments were done at baseline, 24 weeks, and 48 weeks. This minimal follow-up matches usual care.

Score: [5]

Primary outcome

Quotes:

• “Assessments included the Brief Repeatable Battery of Neuropsychological tests (BRB-N)”

Reasoning: The BRB-N measures cognitive domains that are functionally relevant and important to patients.

Score: [5]

Primary analysis

Quotes:

• No discussion of exclusions from analysis

Reasoning: There is no mention of excluding any participants from the analysis. This likely means an intention-to-treat approach was used, matching usual care.

Score: [5]

A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis (2016), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “680.pdf”:

Eligibility criteria

Quotes:

• “Inclusion criteria: 1) having a definite diagnosis of MS from a neurologist; 2) being within 5 years of receiving a diagnosis of MS; 3) scoring at least 10 on the Beck Depression Inventory-II (BDI-II)”

• “Exclusion criteria: Pregnancy, breast feeding, uncontrolled diabetes, peptic ulcer disease, suppurative otitis media, herpes zoster, multiple sclerosis, systematic infection, sarcoidosis and other rare conditions, and an inability to provide informed consent.”

The inclusion criteria are quite broad, including anyone with a definite MS diagnosis and depressive symptoms. The exclusions seem to be mainly for safety reasons. Overall, the eligibility seems reasonably similar to patients who would receive this intervention in usual care.

Score: [3]

Recruitment

Quotes:

• “Participants were recruited through neurologists working in a large MS outpatient clinic at the hospital, advertisements on MS related websites and local press releases.”

Recruitment was done through a specialty MS clinic but also more broadly through websites and press releases. This seems like a mix of clinical and more active recruitment methods.

Score: [3]

Setting

Quote:

• “The study took place at a large teaching and research hospital in Melbourne, Australia. Participants were recruited through neurologists working in a large MS outpatient clinic at the hospital”

The setting is a specialty MS clinic at a single hospital. This seems reasonably similar but still more limited than some usual care settings.

Score: [3]

Organization

Quote:

• “A senior clinical psychologist and a provisional clinical psychologist (supervised by the clinical psychologist) provided the intervention.”

No details are provided about additional resources or training to deliver the intervention. It seems to rely on available staff.

Score: [4]

Flexibility: delivery

Quote:

• “The CBT intervention consisted of 8 individual modules which focused on CBT based principles and strategies.”

The intervention is described as consisting of CBT modules and strategies, but no details are provided on how rigidly it was protocolized. It seems reasonably flexible.

Score: [4]

Flexibility: adherence

No relevant quotes. The text does not mention any specific efforts to enforce adherence.

Score: [4]

Follow-up

Quotes:

• “All participants completed questionnaires at pre- and post-treatment and at 20 weeks follow up.”

• “Follow up assessments ended April, 2015.”

Follow-up is limited to questionnaires at post-treatment and 20 weeks, which does not seem overly intensive.

Score: [4]

Primary outcome

Quotes:

• “The primary outcome was level of depressive symptoms at post and 3 month follow up which was measured with the Beck Depression Inventory-II (BDI-II)”

The primary outcome of depressive symptoms measured by BDI-II is clinically meaningful.

Score: [5]

Primary analysis

Quote:

• “To examine group differences at post and 20 week follow up assessment, individual analyses of covariance (ANCOVAs) were performed with baseline treatment outcome scores used as the covariate.”

Using ANCOVA with baseline scores as a covariate seems like a reasonable analysis approach, but no details are provided to assess handling of missing data.

Score: [NA]

Effect of Fordyce Happiness Model on depression, stress, anxiety, and fatigue in patients with multiple sclerosis (2016), PragMS

Here are the PRECIS-2 scores and rationale for the trial based on the full text:

Eligibility criteria

Relevant quotes:

“The inclusion criteria were being definitely diagnosed with MS and having records in the Society and the exclusion criteria having history of other psychiatric disorders including major depressive disorder (according to the medical records and the physician’s examinations) or bipolar disorder (except for cognitive disorders by which MS is characterized), substance dependency, any neurological disorders, history of taking corticosteroids or the disease recurrence within the previous six months.”

The eligibility criteria seem reasonably inclusive, excluding only patients with comorbid psychiatric disorders that could confound the results. However, patients had to be definitely diagnosed with MS and have records at the MS Society to participate. This may exclude some MS patients who are not engaged with the Society. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Relevant quotes:

“Because the patients were not hospitalized and regularly referred to the Association, to follow randomized assignment, we decided to run the sampling within two consecutive months until we enrolled an adequate number of participants. Accordingly, 70 numbers, equal to the number of people required in each group, were developed and the numbers 1e70 were randomly assigned to two groups: experimental and control. After eligible patients referred to the Association, a number was randomly assigned to each patient according to his/her referring time and the patients were assigned to the two groups.”

Patients were recruited as they presented to the MS Society clinic over 2 months. No extra effort beyond usual clinic recruitment was mentioned. This seems quite pragmatic.

Score: [4]

Setting

Relevant quotes:

The study was conducted at the Multiple Sclerosis Society of Isfahan, Iran.

The setting is a specialty clinic for MS patients, which is likely where many patients receive their usual care. The single center design is moderately pragmatic.

Score: [3]

Organization

Relevant quotes:

No information provided on expertise of staff or resources used. The intervention itself (Fordyce Happiness Model) does not seem to require additional resources.

Score: [NA]

Flexibility: Delivery

Relevant quotes:

“The intervention consisted of: defining depression, stress, anxiety, and their symptoms, defining happiness, and explaining its necessity, reviewing the results of previous studies on happiness (the first session); the technique of increasing physical activity, the technique of being productive, and doing useful and meaningful things (the second session); the principles of planning and better organization–the technique of removing concerns, the technique of reducing expectations and wishes (the third session); the technique of enhancing creativity, the technique of living at present (the fourth session; the technique of increasing social relationships, the technique of being the real self (the fifth session). The technique of increasing intimacy as the most important source of happiness–the technique of giving priority to happiness and making it invaluable (the sixth session); the technique of expressing emotions, the technique of enhancing optimism (the seventh session); reviewing all the techniques taught, administering post-test (the eighth session).”

The intervention consists of training sessions that cover specific topics, suggesting low flexibility in delivery. However, no information is provided on protocol compliance monitoring.

Score: [2]

Flexibility: Adherence

Relevant quotes:

No mention of monitoring or enforcing patient adherence.

Score: [NA]

Follow-up

Relevant quotes:

“Moreover, to investigate the efficacy of the FHM, the DASS-21 and Piper Standard Scale were administered to the experimental group in the follow-up session.”

“The data obtained before and after conduction of the program were analyzed by chi-square test, Mann-Whitney, covariance statistics, repeated measures ANOVA, and independent t-test in SPSS 18.”

Follow-up was done at the end of the 8-week intervention and 3 months later. Outcomes were assessed with questionnaires. Follow-up seems moderately pragmatic.

Score: [3]

Primary Outcome

Relevant quotes:

“To investigate depression, anxiety, and stress, DASS-21, developed by Lovibond and Lovibond in 1995, was used and its validity and reliability were confirmed [17]. To measure fatigue, the Piper Standard Scale was used.”

The primary outcomes of depression, anxiety, stress, and fatigue are patient-important outcomes, assessed with standard instruments. The choice of outcomes is pragmatic.

Score: [4]

Primary Analysis

Relevant quotes:

No mention of how missing data or protocol deviations were handled. Intention-to-treat analysis is not explicitly mentioned.

Score: [NA]

Effect of an intensive 3-day social cognitive treatment (can do treatment) on control self-efficacy in patients with relapsing remitting multiple sclerosis and low disability: A single-centre randomized controlled trial (2019), PragMS

Here are the PRECIS-2 assessments for the trial described in “679.pdf”:

Eligibility criteria

1. “Eligibility criteria for patients: diagnosis RRMS since at least one year, EDSS score ≤4.0, no symptoms suggestive of a relapse, no relapse in the preceding four weeks, willing and capable of participating in the investigations, and having access to the internet for performing the web-based assessments.”

2. The eligibility criteria are fairly broad, including RRMS patients with EDSS scores up to 4.0. The main exclusions are active relapse in the past 4 weeks and inability to complete online assessments. Overall, the criteria seem reasonably similar to patients who would receive this intervention in usual care.

Score: [4]

Recruitment

1. “Participants were recruited from all over the Netherlands by the patient organisation NMSF, Rotterdam, the Netherlands. Interested patients were contacted by a registered nurse experienced in MS (MH) by phone to check diagnosis and eligibility criteria.”

2. Patients were recruited nationwide by a patient organization, contacting them by phone to confirm eligibility. This seems like a reasonably pragmatic approach that could be feasible in routine practice.

Score: [4]

Setting

1. “CDTs were given during three consecutive days in Zorghotel Spelderholt, Beekbergen, the Netherlands, a facility especially equipped for the accommodation of people with impaired health.”

2. The intervention was delivered at a specialized facility for people with impaired health. This is more explanatory than a typical outpatient setting.

Score: [2]

Organization

1. “The multidisciplinary team included a psychiatrist, psychiatric nurse, neurologist, registered nurse specialized in MS, physiotherapist, dance therapist, and a person with MS.”

2. The intervention required a specialized multidisciplinary team including medical specialists, nurses, therapists and a patient expert. This level of resources and expertise exceeds what would be available in usual care.

Score: [2]

Flexibility (delivery)

1. “Components are large group sessions, small group sessions, consultations (carrousel), a theatre evening, and start of the day with a joint activity (optional)”

2. The delivery protocol seems reasonably fixed, with pre-defined components delivered in a structured program. This reduces flexibility compared to usual care.

Score: [3]

Flexibility (adherence)

1. No mention of specific measures to enforce adherence.

2. Adherence does not seem to be directly enforced or monitored. This matches usual care.

Score: [5]

Follow-up

1. “Assessments were at baseline and at one, three and six months follow-up via online questionnaires”

2. Follow-up is limited to online questionnaires at 1, 3 and 6 months. This does not exceed typical follow-up frequency.

Score: [4]

Primary outcome

1. “Primary endpoint was control self-efficacy (Multiple Sclerosis Self-Efficacy Scale Control [MSSES-C]) at six months.”

2. The primary outcome is a patient-centered measure of confidence in managing symptoms and illness demands. This is pragmatic.

Score: [5]

Primary analysis

1. “Intention-to-treat ANCOVA analyses were performed with follow-up values as dependent, and condition, baseline values, disease duration and gender as independent variables.”

2. An intention-to-treat analysis was used including all participants as randomized. This is very pragmatic.

Score: [5]

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial (2013), PragMS

Here are the PRECIS-2 domain scores I would give for this trial along with relevant quotes and reasoning:

Eligibility criteria

Relevant quotes:

• “Participants were included who scored >2 on the General Health Questionnaire 12, a measure of psychological distress, or >7 on the anxiety and depression subscales of the Hospital Anxiety and Depression Scale, thus confirming they had low mood.”

• “Those who were not able to complete the outcome measures, such as people with visual problems, were visited by a researcher who was unaware of their group allocation, who completed the questionnaires with them.”

Reasoning: The eligibility criteria selected participants with low mood, which is appropriate for the aim of evaluating a psychological intervention. People with visual problems were still included by having questionnaires administered by a researcher. Overall, the criteria seem reasonably inclusive and similar to actual practice.

Score: [4]

Recruitment

Relevant quotes:

• “Clusters of eight participants, who could attend groups on the same day, were randomly allocated, using a web-based randomization programme prepared in advance by the Clinical Trials Unit at Nottingham University, to an intervention or control group.”

Reasoning: Participants were recruited in clusters based on ability to attend group sessions. This recruitment process seems specifically designed for the trial rather than reflecting usual care referral.

Score: [2]

Setting

Relevant quotes:

• Not reported

Reasoning: The setting is not clearly described.

Score: [NA]

Organization

Relevant quotes:

• “The groups were delivered by two Band 5 assistant psychologists, who were supervised by a Band 8a clinical psychologist, experienced in working with people with multiple sclerosis.”

Reasoning: The intervention was delivered by psychologists, which represents additional resources compared to usual care.

Score: [2]

Flexibility: delivery

Relevant quotes:

• Not reported

Reasoning: Details on flexibility in delivery are not provided.

Score: [NA]

Flexibility: adherence

Relevant quotes:

• Not reported

Reasoning: Details on flexibility in adherence are not provided.

Score: [NA]

Follow-up

Relevant quotes:

• “Four and eight months after random allocation, participants were sent a booklet of outcome questionnaires to complete and return by post.”

• “If participants failed to return outcome questionnaires they were telephoned once to remind them.”

Reasoning: Follow-up was limited to questionnaires sent by mail with phone reminders if not returned. This does not seem more intensive than usual care.

Score: [4]

Primary outcome

Relevant quotes:

• “To ascertain costs, a questionnaire was used to assess the use of NHS services and prescribed medication in the previous three months.”

• “The EQ-5D was included as a generic quality of life measure.”

Reasoning: The primary outcomes of resource utilization and quality of life seem highly relevant to both participants and health system.

Score: [5]

Primary analysis

Relevant quotes:

• “The main analysis evaluated the total costs of the intervention, resource use and medication at eight months after randomization, but costs at four months follow-up were also recorded.”

• “In the intervention group, there was an overall reduction in resource use from baseline to eight months follow-up of £30,985 (mean per patient reduction of £429).”

Reasoning: The analysis appears to have included all randomized participants without exclusions.

Score: [5]

Is short-term palliative care cost-effective in multiple sclerosis? A randomized phase II trial (2009), PragMS

Here are the PRECIS-2 scores and reasoning for each domain based on the full text in “678.pdf”:

Eligibility criteria

Quotes:

“Patients ≥ 3 with acute respiratory tract infections. Exclusions not common cold but severe respiratory tract infections, peptic ulcer and asthma. But even asthma patients who were not sensitive to ibuprofen or aspirin eligible. Pregnant or breast feeding women are discouraged from taking ibuprofen when pregnant but can take as low a dose as possible of Paracetemol but as both being tested in the trial cannot include this group as participants. If include visually impaired increase organisation of trial (as in carers have to assist diary completion) but that would be norm and usual if prescribed ibuprofen or Paracetemol or steam treatment in usual care, so just easier for trialists to exclude. Small proportion of participants – so why exclude? Depressed and people with psychosis unreliable diary fillers, concerned with other things.”

Reasoning: The eligibility criteria mostly match patients who would receive this treatment in usual care, with some typical exclusions like pregnant women. However, the exclusions of visually impaired, depressed, and psychotic patients seem overly restrictive compared to usual care. Overall quite pragmatic but some limitations.

Score: [4]

Recruitment

Quotes:

“Patients presenting to GP or nurse in primary care with respiratory tract infections as diagnosed by health professional. Easy to recruit to but time pressures in busy winter clinics prevented recruitment and meant non-recruitments logs poorly completed.”

Reasoning: Patients were recruited through normal primary care visits where they would seek treatment for respiratory infections. Very pragmatic recruitment.

Score: [5]

Setting

Quotes:

“Identical setting to usual care setting: primary care, where patients usually go for advice and treatment of the common cold in the UK. Multi-centre: 25 practices in UK.”

Reasoning: The trial was conducted in multiple primary care clinics, which is the typical setting where patients receive treatment for respiratory infections. Very pragmatic setting.

Score: [5]

Organization

Quotes:

“Information sheets given out to participants. This is not usual practice, would it be if trial had shown this helped? Need more staff for follow up of trial participants to get diary results so more extensive data collection than usual. Otherwise no difference in provider expertise and organisation of care delivery.”

Reasoning: The organization was mostly similar to usual care, except for providing information sheets and needing extra staff for follow-up, which made data collection more extensive. Moderately pragmatic.

Score: [3]

Flexibility: Delivery

Quotes:

No relevant quotes.

Reasoning: The text does not seem to describe flexibility in delivery of the intervention.

Score: [NA]

Flexibility: Adherence

Quotes:

“Compliance measured with diary – “reasonably good” participants free to “not-comply” with advice. Little impact of advising patients to take analgesics regularly. No measures to improve compliance”

Reasoning: Patients were free to adhere as in usual care, with no special measures to enforce adherence. Very pragmatic.

Score: [5]

Follow-up

Quotes:

“Participants Followed up one month – usual care no follow up. Patients come back to GP if problems. Trial more extensive data colleaction - patients telephoned day two to three to check for any problems with diary completion. If no diary after 2 weeks then mailed reminder and then phoned as necessary to document outcomes using validated questionnaire.”

Reasoning: Follow-up was more extensive than usual care, with phone calls and reminders to ensure diary completion. Moderately explanatory.

Score: [2]

Primary outcome

Quotes:

“Very relevant to participants - Mean symptom severity on days 2-4. Symptoms 0 (no problem) to 6 (as bad as they can be 7 in abstract). Completed in diary at end of day – children with parents or participants.”

Reasoning: The primary outcome of symptom severity is highly relevant to patients with respiratory infections. Very pragmatic.

Score: [5]

Primary analysis

Quotes:

“ITT no matter whether compliance.”

Reasoning: Primary analysis was intention-to-treat, very pragmatic.

Score: [5]

MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial (2010), PragMS

Here are the PRECIS-2 scores for the trial described in the paper “MS quality of life, depression, and fatigue improve after mindfulness training: A randomized trial”:

Eligibility criteria:

Quotes:

“Neurologists verified all patients for the following inclusion criteria: 1) diagnosis of relapsing-remitting (but no more than 2 exacerbations within the last year) or secondary progressive MS and 2) an Expanded Disability Status Scale (EDSS) score of ≤6 (no to moderately severe disability), with ≤1 step increase within the last year. Excluded were patients with reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety syndromes, evidence of dementia as indicated by testing below the fifth percentile in at least 3 of 6 dimensions of neuropsychological functioning (i.e., attention and concentration, processing speed, executive function, verbal memory, and verbal processing), other currently life-threatening or severely disabling physical disorders, current MS exacerbation, symptomatic MS medication altered in the last 3 months, other disorders of the CNS, pregnancy, or inability to speak or read German.”

Reasoning: The eligibility criteria seem moderately pragmatic. Patients had to have a diagnosis of relapsing-remitting or secondary progressive MS, with some limitations on disability level and recent exacerbations. Some patients were excluded for serious psychological disorders, dementia, other physical disorders, and inability to speak German. Overall, the criteria exclude some patients who may receive the intervention in usual care, but still target a reasonably broad patient population.

Score: [3]

Recruitment:

Quotes: No relevant quotes.

Reasoning: The paper does not provide any details on how patients were recruited.

Score: [NA]

Setting:

Quotes: No relevant quotes.

Reasoning: The paper does not provide any details on the setting of the trial.

Score: [NA]

Organization:

Quotes: No relevant quotes.

Reasoning: The paper does not provide any details on the organization of care delivery in the trial.

Score: [NA]

Flexibility of experimental intervention - Delivery:

Quotes:

“MBI closely followed the program of mindfulness-based stress reduction and included 1) a personal intake interview to define realistic goals of participants and establish personal rapport; 2) 8 weekly 2.5-hour classes in mindfulness practices (10–15 participants/group; exercises did not exceed patients’ level of functioning); 3) one Saturday, 7-hour session at week 6; 4) homework assignments (approximately 40 minutes/day), emphasized as essential to success of the program; 5) a postintervention interview to evaluate personal experiences, goal attainment, and future maintenance of acquired skills. Each class covered specific exercises and topics within the context of mindfulness training, i.e., practices during lying, sitting, and dynamic yoga postures, as well as during everyday life, e.g., stressful situations and social interactions. Mindfulness exercises included observation of sensory, affective, and cognitive domains of perceptible experience. The all-day retreat integrated familiar exercises and presented new ones. In all, 6 MBI courses for the experimental arm of the study were individually conducted by 2 experienced, certified teachers, each with ≥9 years teaching experience.”

Reasoning: The delivery of the mindfulness intervention seems moderately flexible, following a structured program with specific components and exercises. But there was some flexibility in tailoring to patients’ functioning level and goals.

Score: [3]

Flexibility of experimental intervention - Adherence:

Quotes: No relevant quotes.

Reasoning: The paper does not provide any details on measures to enforce adherence.

Score: [NA]

Follow-up:

Quotes:

“Reported outcome measurements occurred within 2 weeks before and after intervention and 6 months postintervention.”

Reasoning: Patients were followed up at 2 time points - post-intervention and 6 months. This seems moderately pragmatic.

Score: [3]

Primary outcome:

Quotes:

“Primary outcomes included disease-specific and disease-aspecific HRQOL, depression, and fatigue.”

Reasoning: The primary outcomes of HRQOL, depression, and fatigue are meaningful and relevant to patients.

Score: [5]

Primary analysis:

Quotes:

“Intention-to-treat analyses are reported. Data of missing study patients were imputed by linear multiple regression that adjusted for age, gender, and disease progression (entry EDSS score; STATISTICA 6.0).”

Reasoning: An intention-to-treat analysis was used, which is pragmatic.

Score: [5]

Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients (2016), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in the paper “Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients”:

Eligibility criteria

Quotes:

• “Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE-MS II), a 2-year randomized, rater-blinded, active-controlled, head-to-head, phase 3 trial, compared efficacy and safety of alemtuzumab 12 mg with subcutaneous interferon-β-1a (SC IFN-β-1a) 44 mg in patients with RRMS.”

• “CARE-MS II was a 2-year, randomized, rater-blinded, active comparator-controlled, head-to-head, trial of alemtuzumab (Lemtrada; Sanofi Genzyme, Cambridge, MA; 12 mg/day on 5 consecutive days at month 0 and on 3 consecutive days at month 12) vs SC IFN-β-1a (Rebif; EMD Serono, Rockland, MA; 44 mg 3 times weekly) in patients with RRMS with inadequate response to prior DMTs (≥1 relapse during IFN-β or glatiramer acetate [GA] treatment [received for ≥6 months]).”

Explanation: The eligibility criteria include patients with RRMS who have had at least 1 relapse during prior treatment with IFN-β or GA for at least 6 months. This reflects a patient population that would be reasonably expected to receive alemtuzumab or SC IFN-β-1a in usual clinical practice. Some patients are excluded that may have been eligible in usual care, such as those with non-RRMS forms of MS. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Quote: “In total, 202 and 426 CARE-MS II patients were randomized to SC IFN-β-1a 44 mg and alemtuzumab 12 mg, respectively.”

Explanation: The paper does not provide details on how patients were recruited, other than saying they were randomized. Without more information, it is difficult to assess the pragmatism of recruitment.

Score: [NA]

Setting

Quote: “CARE-MS II was a 2-year, randomized, rater-blinded, active comparator-controlled, head-to-head, trial of alemtuzumab (Lemtrada; Sanofi Genzyme, Cambridge, MA; 12 mg/day on 5 consecutive days at month 0 and on 3 consecutive days at month 12) vs SC IFN-β-1a (Rebif; EMD Serono, Rockland, MA; 44 mg 3 times weekly) in patients with RRMS with inadequate response to prior DMTs (≥1 relapse during IFN-β or glatiramer acetate [GA] treatment [received for ≥6 months]).”

Explanation: The setting is not described in detail, but it seems to be a typical clinical trial setting across multiple centers/countries. It is unclear how similar the settings are to real-world clinical settings. Without more details, the pragmatism is difficult to judge.

Score: [NA]

Organization

Quotes:

• “Blinded raters performed EDSS assessments at baseline, every 3 months, and when relapse was suspected.”

• “Raters administered the MSFC 3 times before baseline to attenuate practice effects, then every 6 months.”

Explanation: The paper mentions that blinded raters performed assessments like EDSS and MSFC. It does not provide much detail on the expertise of staff or resources available. It seems reasonably similar to a real-world clinic in terms of staffing for assessments.

Score: [3]

Flexibility: Delivery

Quote: “Differences in study drug administration and unique adverse event profiles precluded effective double-blinding.”

Explanation: The paper mentions differences in drug administration between the two arms, but does not provide specifics. Without more details, it is hard to judge the flexibility of delivery.

Score: [NA]

Flexibility: Adherence

No relevant quotes

Explanation: The paper does not mention any strategies to enforce or monitor adherence. However, it also provides no details to suggest flexibility in adherence.

Score: [NA]

Follow-up

Quotes:

• “Blinded raters performed EDSS assessments at baseline, every 3 months, and when relapse was suspected.”

• “Raters administered the MSFC 3 times before baseline to attenuate practice effects, then every 6 months.”

Explanation: Patients were followed regularly with assessments every 3 months for EDSS and every 6 months for MSFC. This seems moderately frequent but not excessive compared to real-world practice.

Score: [3]

Primary outcome

Quote: “EDSS-based and non-EDSS-based methods. The results of these prespecified outcomes and post hoc analyses from CARE-MS II more fully characterize the effects of alemtuzumab on disability in patients with RRMS than those published previously”

Explanation: The primary outcomes include EDSS and MSFC which measure disability and are clinically meaningful to patients.

Score: [5]

Primary analysis

Quote: “An intention-to-treat analysis has recently also become the norm for superiority trials taking a more explanatory design approach, especially when regulatory approval for an intervention is being sought.”

Explanation: The paper mentions that intention-to-treat analysis has become standard, even for explanatory trials. No other analysis details are provided.

Score: [NA]

Exercise in the community for people with minimal gait impairment due to MS: an assessor-blind randomized controlled trial (2013), PragMS

Here are the PRECIS-2 scores for the trial based on the publication full text:

Eligibility criteria

Quotes:

1. “Eligible participants were over 18 years of age and had a diagnosis of MS that was confirmed by a consultant physician or neurologist.”

2. “Persons with MS were excluded if they had a previous relapse or began steroid therapy in the 12 weeks prior to participating in the first assessment, were pregnant, or had a comorbidity that severely impacted their ability to safely participate in exercise.”

Reasoning: The eligibility criteria are reasonably broad, including adults with confirmed MS diagnosis. Some exclusions are made for safety reasons like recent relapse, pregnancy, and comorbidities impacting exercise safety. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Quotes:

1. “Participants were referred to the project by themselves, their care-giver, MSI, chartered physiotherapists, neurologists, general practitioners or clinical nurse specialists.”

2. “Once consent for eight people of a strand in a specific geographical area was obtained, the regional office of MSI contacted the national coordinator (AL) who allocated that block of participants to the control or an intervention.”

Reasoning: Participants were recruited through usual care referrals from physicians and self-referrals. The recruitment seems moderately pragmatic overall, leveraging usual care routes but with some extra coordination for grouping and randomization.

Score: [3]

Setting

Quote: “This was a multi-centre, block randomised, assessor blind, controlled study. The methods of the trial were previously described in detail. This paper presents the results of the study participants, who used at the most unilateral support to walk outdoors”

Reasoning: The trial was conducted across multiple centers, suggesting a pragmatic setting close to usual care.

Score: [4]

Organization

Quote: “All interventions took place in groups of eight, for an hour per week, for 10 weeks. They were delivered in community centres such as local gyms, hotels and health centres.”

Reasoning: The interventions were delivered in community settings using existing resources, suggesting a pragmatic organization.

Score: [4]

Flexibility: delivery

Quotes:

1. “The PT-led exercise provided was pre-defined. It consisted of a circuit-style class of exercises that were either resisted by body weight or by the addition of free weights.”

2. “The yoga intervention was also not predefined, and detailed descriptions of the classes were gathered by nine of the instructors.”

Reasoning: The PT-led intervention was protocolized while the yoga intervention was flexible. Overall, the delivery seems moderately pragmatic.

Score: [3]

Flexibility: adherence

No relevant quotes.

Reasoning: The text does not mention any measures to enforce adherence. I will assume a pragmatic approach was taken since nothing is specified.

Score: [4]

Follow-up

Quote: “Outcome was assessed at week 24 for the intervention groups only, as it was felt that withholding a potentially beneficial treatment for longer than 12 weeks, from the controls, could be considered unethical. As all groups were not treated similarly between weeks 12 and 24, and due to the high attrition rates at weeks 12 and 24, the results of our follow-up phase will be presented in a separate paper.”

Reasoning: Follow-up was limited to 12 weeks even for the control group to avoid withholding treatment. This seems reasonably pragmatic.

Score: [4]

Primary outcome

Quotes:

1. “The primary outcome measure was the physical component of the Multiple Sclerosis Impact Scale-29, version 2 (MSIS-29v2), a patient-reported outcome measure that assesses the physical impact of MS.”

2. “It consists of 20 questions and it is scored from 0–100, with the higher scores indicating a greater impact of MS.”

Reasoning: The primary outcome is a patient-reported measure of MS physical impact, which seems highly pragmatic and relevant to participants.

Score: [5]

Primary analysis

Quote: “All participants were analysed in the groups to which they were randomised.”

Reasoning: An intention-to-treat analysis was used, suggesting a pragmatic approach.

Score: [5]

Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis (2019), PragMS

Here are the PRECIS-2 domain scores for the trial with supporting quotes and explanations:

Eligibility Criteria

Quotes:

“Inclusion criteria - Patients ≥3 with acute respiratory tract infections. Exclusions not common cold but severe respiratory tract infections, peptic ulcer and asthma. But even asthma patients who were not sensitive to ibuprofen or aspirin eligible. Pregnant or breast feeding women are discouraged from taking ibuprofen when pregnant but can take as low a dose as possible of Paracetemol but as both being tested in the trial cannot include this group as participants. If include visually impaired increase organisation of trial (as in carers have to assist diary completion) but that would be norm and usual if prescribed ibuprofen or Paracetemol or steam treatment in usual care, so just easier for trialists to exclude. Small proportion of participants – so why exclude?”

Reasoning: The eligibility criteria are quite broad, including patients with acute respiratory tract infections who would receive the intervention in usual care. Some common exclusions are made for safety reasons or to simplify trial procedures, but overall the criteria seem pragmatic.

Score: [4]

Recruitment

Quotes:

“Patients presenting to GP or nurse in primary care with respiratory tract infections as diagnosed by health professional. Easy to recruit to but time pressures in busy winter clinics prevented recruitment and meant non-recruitments logs poorly completed.”

Reasoning: Patients were recruited through usual appointments in primary care, which is a very pragmatic approach. Some non-recruitment due to time pressures indicates that recruitment conditions were similar to real-world constraints.

Score: [5]

Setting

Quotes:

“Identical setting to usual care setting: primary care, where patients usually go for advice and treatment of the common cold in the UK.”

“Multi-centre: 25 practices in UK.”

Reasoning: The setting of primary care clinics is identical to where patients would receive treatment in usual practice. Multiple sites were used to increase generalizability.

Score: [5]

Organization

Quotes:

“Information sheets given out to participants. This is not usual practice, would it be if trial had shown this helped? Need more staff for follow up of trial participants to get diary results so more extensive data collection than usual. Otherwise no difference in provider expertise and organisation of care delivery.”

Reasoning: The intervention was delivered with existing primary care staff and resources. Some additional materials and data collection were required for the trial but unlikely to affect care delivery.

Score: [4]

Flexibility: Delivery

Quotes:

“Full flexibility”

Reasoning: No protocol prescribed how providers should deliver the intervention, indicating full flexibility.

Score: [5]

Flexibility: Adherence

Quotes:

“Compliance measured with diary – “reasonably good” participants free to “not-comply” with advice. Little impact of advising patients to take analgesics regularly. No measures to improve compliance”

Reasoning: Adherence was measured but participants were free to follow the advice or not. No special measures were used to enforce adherence.

Score: [5]

Follow-Up

Quotes:

“Participants Followed up one month – usual care no follow up. Patients come back to GP if problems. Trial more extensive data colleaction - patients telephoned day two to three to check for any problems with diary completion. If no diary after 2 weeks then mailed reminder and then phoned as necessary to document outcomes using validated questionnaire.”

Reasoning: One month follow-up is more than usual care. Additional contacts were made to collect trial data but unlikely to affect care.

Score: [3]

Primary Outcome

Quotes:

“Very relevant to participants - Mean symptom severity on days 2-4. Symptoms 0 (no problem) to 6 (as bad as they can be 7 in abstract). Completed in diary at end of day – children with parents or participants.”

Reasoning: Symptom severity is a very relevant outcome that was self-reported by patients.

Score: [5]

Primary Analysis

Quotes:

“ITT no matter whether compliance.”

Reasoning: An intention-to-treat approach was used with no exclusions based on compliance.

Score: [5]

Effects of an individual 12-week community-located “start-to-run” program on physical capacity, walking, fatigue, cognitive function, brain volumes, and structures in persons with multiple sclerosis (2014), PragMS

Here are the PRECIS-2 domain scores and explanations for the trial in the attached paper “670.pdf”:

Eligibility:

Relevant quotes:

“The inclusion criterion for the study was a diagnosis of multiple sclerosis, and therefore the spectrum of clinical presentations was broad, as would be expected in this client population.”

“Of the fifteen study participants, all had previously received a diagnosis of multiple sclerosis. The time since diagnosis ranged from three to forty-one years (with a mean of 19 years) at the time of the study. Nine participants were categorized as Relapse eRemitting, four as Secondary Progressive and two as Primary Progressive.”

“With respect to the ambulatory status of the participants, six walked unassisted, five used a cane, and four used a walker. All participants had prior experience of massage treatment at the clinic.”

Reasoning: The inclusion criterion of a diagnosis of MS is very broad and appears to match usual care eligibility. The participants represented a range of MS types and disability levels, reflecting a heterogeneous MS population typically seen in practice. The broad eligibility criteria yield a pragmatic trial design aimed at determining effectiveness under usual conditions.

Score: [5]

Recruitment:

Relevant quotes:

“Clients attending the clinic were interviewed, and their case histories recorded. The research project was explained, and written informed consent was obtained.”

“An appropriate history and physical examination was performed, and a treatment plan determined, this being reflective of the therapist’s assessment and the mutually set goals for the treatment series.”

Reasoning: Participants were recruited when they attended the clinic for usual care, which matches how they would receive this intervention under normal circumstances. No additional effort was made to recruit beyond those presenting for care.

Score: [5]

Setting:

Relevant quotes:

“Participants were clients seen in the multiple sclerosis clinics at Sutherland-Chan School, in which the study was conducted.”

“Clients were provided with information about the clinic by the local chapter of the Multiple Sclerosis Society, and self selected on that basis.”

Reasoning: The setting was a multiple sclerosis specialty clinic, which appears to be the typical setting where these patients receive massage therapy. Conducting the trial in this real-world clinical setting matches the intended application.

Score: [5]

Organisation:

Relevant quotes:

“The teacher also monitored treatment delivery, which involved the application of a variety of techniques appropriate to the client’s needs. These included effleurage, petrissage, stroking, frictions, vibrations, tapotment, rocking and shaking, details of which have been reviewed by Yates (2004). These techniques all involve the manipulation of soft tissues to which was added joint mobilization, myofascial techniques, rehabilitative exercise and hydrotherapy in order to reflect the broad therapeutic armamentarium of the massage therapist.”

Reasoning: The massage therapy was delivered by supervised student therapists using typical resources and a variety of techniques tailored to each participant’s needs. This matches how massage therapy is organized and provided in real-world practice.

Score: [5]

Flexibility (delivery):

Relevant quotes:

“Massage therapy is aligned with the wellness paradigm of health and health care (Alexander, 2006; Yates, 2004), which speaks to a holistic client centered approach to treatment. Accordingly, if the current research was to conform to the requirements of model fit/ecological validity (Menard, 2003; Mason et al., 2002), it was incumbent on the therapists to construct individualized treatment plans recognizing the importance of the client’s physical, psychological and emotional needs. The heterogeneity of the client/participant population precluded an overly prescriptive approach to treatment, and it is worth noting that this heterogeneity is also a component of the normal clinical reality of therapists involved with multiple sclerosis clients.”

Reasoning: The massage therapy was individualized for each participant based on presenting symptoms and tailored goals. No protocol was prescribed, allowing flexibility to match real-world practice.

Score: [5]

Flexibility (adherence):

Relevant quotes: None relevant.

Reasoning: The paper does not mention any strategies to enforce or monitor adherence. In the absence of information, it appears there was no difference from usual care.

Score: [5]

Follow-up:

Relevant quotes:

“For both treatment and control groups, self-efficacy scores were obtained before the first treatment, mid-treatment series, after the last treatment in the series, four weeks after the final treatment and again eight weeks after the final treatment had been received.”

Reasoning: Follow-up was limited to 5 assessment time points to measure the primary outcome. This does not seem more extensive than usual care.

Score: [5]

Primary outcome:

Relevant quotes:

“The outcome measures for the current research were the scores yielded by the Multiple Sclerosis Self Efficacy (MSSE) survey.”

“The nature of the MSSE survey is such that the clients’ self-efficacy rating is captured through a series of eighteen questions to which they respond on a scale ranging from ten to one hundred. The instrument focuses on the clients’ perception of their ability to function, and the degree of control they have within the context of their disease state.”

“In the context presented above, the use of MSSE scores as the outcome measure in the current research reflects the notion that massage therapy has the potential to improve client well-being and adjustment to living with multiple sclerosis, through improving perceptions of function and control.”

Reasoning: The primary outcome was self-efficacy measured by the MSSE survey, which assessses patients’ perceived ability to function and degree of control. This outcome is relevant and meaningful to the participants.

Score: [5]

Primary analysis:

Relevant quotes:

“The data were analyzed on an intention to treat basis, with a focus on the differences between mean MSSE values of the control and intervention groups.”

Reasoning: An intention-to-treat analysis was used including all participants as randomized. This pragmatic approach to analysis matches the intended purpose.

Score: [5]

Clinical assessment of the HELLODOC tele-rehabilitation service (2008), PragMS

Here are the PRECIS-2 domain scores and reasoning based on the provided full text:

Eligibility criteria

Relevant quotes:

“Patients ≥ 3 with acute respiratory tract infections. Exclusions not common cold but severe respiratory tract infections, peptic ulcer and asthma. But even asthma patients who were not sensitive to ibuprofen or aspirin eligible. Pregnant or breast feeding women are discouraged from taking ibuprofen when pregnant but can take as low a dose as possible of Paracetemol but as both being tested in the trial cannot include this group as participants. If include visually impaired increase organisation of trial (as in carers have to assist diary completion) but that would be norm and usual if prescribed ibuprofen or Paracetemol or steam treatment in usual care, so just easier for trialists to exclude. Small proportion of participants – so why exclude? Depressed and people with psychosis unreliable diary fillers, concerned with other things.”

Score: [4] Rather pragmatic

The eligibility criteria mostly match those who would receive the intervention in usual care, with some minor exclusions for practical trial reasons like visual impairment and mental health issues that could affect diary completion. Overall the criteria seem designed to maximize applicability.

Recruitment

Relevant quotes:

“Patients presenting to GP or nurse in primary care with respiratory tract infections as diagnosed by health professional. Easy to recruit to but time pressures in busy winter clinics prevented recruitment and meant non-recruitments logs poorly completed.”

Score: [5] Very pragmatic

Patients were recruited through their usual primary care appointments, matching how they would receive the intervention in real-world practice. No extra recruitment efforts were mentioned.

Setting

Relevant quotes:

“Identical setting to usual care setting: primary care, where patients usually go for advice and treatment of the common cold in the UK. Multi-centre: 25 practices in UK.”

Score: [5] Very pragmatic

The trial was conducted in real-world primary care settings across multiple centers, maximizing applicability.

Organization

Relevant quotes:

“Information sheets given out to participants. This is not usual practice, would it be if trial had shown this helped? Need more staff for follow up of trial participants to get diary results so more extensive data collection than usual. Otherwise no difference in provider expertise and organisation of care delivery.”

Score: [3] Equally pragmatic and explanatory

Extra staff were needed for follow-up, but otherwise organization matched usual care. The information sheets do not affect care delivery. Overall somewhat mixed pragmatism.

Flexibility: delivery

Relevant quotes:

No relevant quotes provided in the text.

Score: [NA]

Flexibility: adherence

Relevant quotes:

“Compliance measured with diary – “reasonably good” participants free to “not-comply” with advice. Little impact of advising patients to take analgesics regularly. No measures to improve compliance”

Score: [5] Very pragmatic

Patients were free to adhere as in usual care, with no special measures to enforce compliance. Maximally pragmatic.

Follow-up

Relevant quotes:

“Patients Followed up one month – usual care no follow up. Patients come back to GP if problems. Trial more extensive data colleaction - patients telephoned day two to three to check for any problems with diary completion. If no diary after 2 weeks then mailed reminder and then phoned as necessary to document outcomes using validated questionnaire.”

Score: [2] Rather explanatory

Follow-up was more extensive than usual care to ensure diary completion, reducing pragmatism.

Primary outcome

Relevant quotes:

“Very relevant to participants - Mean symptom severity on days 2-4. Symptoms 0 (no problem) to 6 (as bad as they can be 7 in abstract). Completed in diary at end of day – children with parents or participants.”

Score: [5] Very pragmatic

The patient-centered symptom severity outcome matches what is important to participants in real-world practice. Maximally pragmatic choice.

Primary analysis

Relevant quotes:

“ITT no matter whether compliance.”

Score: [5] Very pragmatic

An intention-to-treat analysis was used, with no exclusions based on compliance. Maximally pragmatic.

Group-Based Individualized Comprehensive Core Stability Intervention Improves Balance in Persons With Multiple Sclerosis: A Randomized Controlled Trial. (2019), PragMS

Here are the PRECIS-2 scores and reasoning for each domain based on the full text in “657.pdf”:

Eligibility criteria

Quotes:

• “Eighty people completed baseline testing.”

• “Inclusion criteria were as follows: (1) diagnosed with MS in accordance with the McDonald criteria; (2) registered at the MS outpatient clinic; (3) living in 1 of 6 selected municipalities; (4) aged 18 years or older; (5) capable of providing signed written informed consent; and (6) EDSS score between 1 and 6.5 (1 = minor disability, 6.5 = able to walk 20 m with or without a walking aid).”

• “Exclusion criteria were as follows: (1) pregnancy at time of examination; (2) exacerbation in the previous 2 weeks before enrollment; and (3) other acute conditions compromising balance.”

Reasoning: The eligibility criteria are fairly broad, including adults with all types of MS and a wide range of disability levels, which matches the intended population for the intervention. Some common exclusions like pregnancy and recent exacerbations are reasonable. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment

Quotes:

• “In August 2015, 1 of the MS nurses at the Department of Neurology, Nordland Hospital Trust in Bodø, Norway, sent out invitation letters with a consent form to 160 persons with MS who were registered at the MS outpatient clinic, had EDSS scores of 0 to 7, and lived in 1 of the 6 municipalities included in the study.”

• “To ensure maximum patient enrollment, 1 reminder letter was sent out to the nonresponders.”

Reasoning: Participants were recruited from an MS clinic registry, reflecting the intended population and care setting. Extra efforts like reminder letters were used to boost enrollment. Overall, recruitment seems moderately pragmatic.

Score: [3]

Setting

Quotes:

• “The study was approved by the Regional Committees for Medical and Health Research Ethics in Norway, and the study complied with the Declaration of Helsinki.”

• “Six neurological physical therapists conducted the intervention after being trained in GroupCoreDIST for 5 days.”

• “Participants allocated to the intervention group were divided into 13 training groups by B.N. and E.C.A. according to geography.”

• “Assessments at all time points took place at a Norwegian hospital.”

Reasoning: The setting was multiple sites in Norway, reflecting a typical real-world care setting for the population. Assessments were done at a hospital site. Overall, the setting seems pragmatic.

Score: [4]

Organization

Quotes:

• “Six neurological physical therapists conducted the intervention after being trained in GroupCoreDIST for 5 days. The training included practical and theoretical training.”

• “The physical therapists had varied experience (between 7–25 years) and certification (2 had both a master’s degree in neurological physical therapy and were clinical specialists in neurological physical therapy, 1 was a clinical specialist in neurological physical therapy, and 3 were generalists in physical therapy).”

Reasoning: The providers had some specialized training and expertise in neurological physical therapy, which was likely needed to properly deliver the intervention. But this level of expertise seems reasonable for this setting and population. No major additional resources were noted. Overall, organization seems moderately pragmatic.

Score: [3]

Flexibility: delivery

Quotes:

• “The physical therapists conducted an individual clinical examination of each participant. The examinations were followed by group sessions, in which the physical therapists chose from 33 exercises, all with 5 levels of difficulty to address each individual’s impairments underlying his or her balance disturbance. The physical therapists individualized the exercises by tailoring them according to each individual’s symptoms, disability level, and general well-being, and they intensified the exercises by increasing number of repetitions, level of difficulty, and/or by adding motor-cognitive dual tasks as movement quality improved.”

Reasoning: The intervention involved individualized tailoring and clinical judgment in delivery, providing flexibility similar to real-world practice. But the protocol still guided the overall standardized intervention. Delivery seems moderately pragmatic.

Score: [3]

Flexibility: adherence

Quotes:

• “All group members received a booklet with illustrations of the exercises in which the physical therapist prescribed unsupervised home exercises to be conducted twice per week for 30 minutes.”

• “Participants in the intervention group were encouraged not to seek any physical therapy other than GroupCoreDIST during the 6 weeks of the intervention.”

Reasoning: Participants were encouraged to follow the prescribed exercises at home but no special measures to enforce adherence were mentioned. Adherence seems to have been handled in a reasonably pragmatic way.

Score: [4]

Follow-up

Quotes:

• “Assessments were undertaken at baseline and at weeks 7, 18, and 30.”

• “The participants were allowed to use a walking aid if preferred and were encouraged to use the same walking aid and shoes for all assessments.”

Reasoning: Follow-up visits aligned with outcome assessments at 7, 18, and 30 weeks post-intervention. This schedule seems more frequent than typical care but is reasonable for research purposes. Overall moderately pragmatic.

Score: [3]

Primary outcome

Quotes:

• “The outcome measures were the Trunk Impairment Scale–Norwegian Version (TIS-NV), the Mini Balance Evaluation Systems Test (Mini-BESTest), and the Patient Global Impression of Change–Balance (PGIC-Balance).”

Reasoning: The primary outcomes of balance and trunk control are clinically meaningful to patients. The measures used are reasonably pragmatic.

Score: [4]

Primary analysis

Quotes:

• “To examine possible differences between groups over time, we performed an intention-to-treat analysis using repeated-measures mixed models in IBM SPSS Version 24.”

• “All participants with postintervention test assessment scores were included, although some had missing observations.”

Reasoning: The analysis was intention-to-treat including all participants, a pragmatic approach.

Score: [5]

Distress improves after mindfulness training for progressive MS: A pilot randomised trial (2015), PragMS

Here are the PRECIS-2 domain scores for the trial described in the attached publication “662.pdf”:

Eligibility criteria:

Relevant quotes:

“Inclusion criteria were diagnosis of PPMS or SPMS, Internet access and some level of distress determined by a score of 3 or greater on the General Health Questionnaire (GHQ-12).”

“Exclusion criteria were severe cognitive impairment, as determined by a score of 20 or smaller on the Telephone Interview for Cognitive Status-Modified (TICS-M)”

“Finally, people were excluded if they reported any serious psychological disorders (e.g. psychosis, substance abuse), severe hearing impairment, attending other psychological therapies or prior formal training in mindfulness.”

The eligibility criteria include patients with PPMS and SPMS which are the target population for the intervention. However, patients with severe cognitive impairment, serious psychological disorders, hearing impairment, or prior mindfulness training are excluded even though they may benefit from and receive the intervention in usual care. The distress screening using GHQ-12 may also exclude some patients who would receive the intervention in usual care. Overall, the criteria exclude some patients who may receive the intervention in usual care.

Score: [3]

Recruitment:

Relevant quotes:

“We recruited potential participants through adverts on the MS Society website and from National Health Service (NHS) MS centres across the UK.”

The participants were recruited through the MS Society website and NHS clinics. Recruiting through usual care clinics is pragmatic, but additional recruitment through website advertisements makes it slightly less pragmatic. Overall, recruitment is a mix of routine clinic recruitment and extra effort through websites.

Score: [3]

Setting:

Relevant quotes:

“Recruitment took place between December 2012 and May 2013. We administered the screening questionnaires via telephone.”

No details provided on number or types of sites. Likely multi-center given recruitment from NHS centers across the UK, but not clearly specified.

Score: [NA]

Organization:

Relevant quotes:

“AB, a health psychologist, facilitated the courses. AB was supervised by PC, a clinical psychologist and expert mindfulness practitioner.”

The intervention was delivered by a health psychologist with training in mindfulness. No mention of additional resources or expertise beyond what would be available in usual care.

Score: [5]

Flexibility of experimental intervention - delivery:

Relevant quotes:

“The format and manual for the mindfulness group, including length of sessions and individual mindfulness practices, were developed in partnership with patients with MS through initial experimental case studies.”

The delivery of the intervention was adapted based on feedback from patients to be suitable for those with limited mobility. However, the format was still standardized based on a manual. Some flexibility but not as much as typical usual care.

Score: [3]

Flexibility of experimental intervention - adherence:

Relevant quotes:

No relevant quotes.

No mention of monitoring or enforcing adherence. Appears to be standard encouragement.

Score: [5]

Follow-up:

Relevant quotes:

“Participants completed online questionnaires at baseline (prior to randomisation), post-intervention and three-month follow-up.”

Follow-up assessments at two time points. No mention of additional in-person visits beyond online questionnaires. Follow-up limited to standardized questionnaires.

Score: [4]

Primary outcome:

Relevant quotes:

“The GHQ is uncontaminated by the experience of MS-related somatic symptoms and is the most treatment-responsive measure of psychological distress in MS.”

The primary outcome was level of distress measured by GHQ score. This measures a clinically meaningful outcome that is relevant to patients.

Score: [5]

Primary analysis:

Relevant quotes:

No relevant quotes.

No details provided on primary analysis.

Score: [NA]

How do resistance training and balance and motor control training affect gait performance and fatigue impact in people with multiple sclerosis? A randomized controlled multi-center study (2020), PragMS

Here are the PRECIS-2 scores and explanations for the trial described in “663.pdf”:

Eligibility criteria

Quotes:

• “Inclusion criteria—Patients ≥ 3 with acute respiratory tract infections.”

• “Exclusions not common cold but severe respiratory tract infections, peptic ulcer and asthma.”

• “Extra test—Randomised controlled trial of Bell’s palsy treatment required senior otorhinolaryngologist in hospitals to confirm a patient’s eligibility to participate. Bell’s palsy is usually diagnosed by a general practitioner in primary care.”

The eligibility criteria are rather explanatory as patients had to be confirmed by a specialist, even though Bell’s palsy is usually diagnosed by a general practitioner. There are also several exclusion criteria that would not apply in usual care.

Score: [2]

Recruitment

Quotes:

• “Patients presenting to GP or nurse in primary care with respiratory tract infections as diagnosed by health professional.”

• “Recruitment was inadequate using a postal questionnaire, so participants were then recruited through clinic attendances…”

Recruitment started pragmatically through usual appointments but then became more explanatory by using a postal questionnaire. Overall it seems to be a mix of methods, some feasible in usual care.

Score: [3]

Setting

Quotes:

• “Identical setting to usual care setting: primary care, where patients usually go for advice and treatment of the common cold in the UK.”

• “Multi-centre: 25 practices in UK.”

The setting is very pragmatic, identical to usual care and involving multiple centres.

Score: [5]

Organisation

Quote:

• “Information sheets given out to participants. This is not usual practice, would it be if trial had shown this helped? Need more staff for follow up of trial participants to get diary results so more extensive data collection than usual. Otherwise no difference in provider expertise and organisation of care delivery.”

The organisation is moderately pragmatic - some additional resources for follow-up but otherwise similar expertise and delivery.

Score: [3]

Flexibility: Delivery

Quote:

• “Full flexibility”

No protocol or measures to improve compliance, so very pragmatic flexibility in delivery.

Score: [5]

Flexibility: Adherence

Quotes:

• “Compliance measured with diary – “reasonably good” participants free to “not-comply” with advice. Little impact of advising patients to take analgesics regularly. No measures to improve compliance”

No special measures to enforce adherence, very pragmatic.

Score: [5]

Follow-up

Quotes:

• “Participants Followed up one month – usual care no follow up. Patients come back to GP if problems.”

• “Trial more extensive data colleaction - patients telephoned day two to three to check for any problems with diary completion. If no diary after 2 weeks then mailed reminder and then phoned as necessary to document outcomes using validated questionnaire.”

More intensive follow-up than usual care to collect trial data. Moderately explanatory.

Score: [2]

Primary outcome

Quotes:

• “Very relevant to participants - Mean symptom severity on days 2-4. Symptoms 0 (no problem) to 6 (as bad as they can be 7 in abstract). Completed in diary – children with parents or participants.”

Symptom severity very relevant to patients. Pragmatic choice.

Score: [5]

Primary analysis

Quote:

• “ITT no matter whether compliance.”

Intention-to-treat analysis very pragmatic.

Score: [5]

Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis: a randomised controlled trial (2014), PragMS

Here are the PRECIS-2 domain scores and explanations for the trial described in the paper “Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis: a randomised controlled trial” (664.pdf):

Eligibility criteria:

Relevant quotes:

“The inclusion criteria for the trial were clinical diagnosis of MS, as defined by the modified McDonald criteria, with an Expanded Disability Status Scale (EDSS) score of 1.0–6.5, and able to walk a 10-metre distance; aged 18–65 years; clinically stable for at least four weeks prior to entering the study; physically able to participate in exercise three times per week; able to provide written informed consent.”

“Exclusion criteria were comorbid conditions impairing the ability to be physically active three times per week; unwilling to be randomised; living more than 20 miles from the trial centre; already engaged in structured exercise or brisk walking ≥ 3 times per week for ≥ 30 minutes per session for at least six months.”

Reasoning: The eligibility criteria are reasonably broad, including patients with mild to moderate MS based on EDSS score who are able to walk at least 10 meters. The main exclusions are comorbidities impairing physical activity, living too far away, and already exercising regularly. This seems fairly similar to criteria that would be used in usual care.

Score: [4] Rather pragmatic

Recruitment:

Relevant quotes:

“A total of 120 PwMS were recruited via the Sheffield MS Clinic and flyers/community adverts displayed at the local South Yorkshire MS Society branches.”

Reasoning: Participants were recruited through a MS clinic and local community adverts, which seems like a reasonably pragmatic approach that could be implemented in usual care. No extra incentives for participation are mentioned.

Score: [4] Rather pragmatic

Setting:

Relevant quotes:

“Supervised exercise sessions involved up to three participants and lasted for approximately one hour. Studies show that aerobic exercise, resistance exercise and combined programmes bring health benefits to PwMS. Hence, the programme was designed to be pragmatic and accessible, taking into account exercise preferences and giving choices.”

“Where appropriate, participants also performed exercises for strength and control. The prescribed strength training was based on individual functional needs, as assessed by the trial physiotherapist (NS).”

Reasoning: The supervised exercise sessions took place at a university exercise research facility with supervision from an exercise physiologist and physiotherapist input. This specialized setting is more explanatory than a typical clinical setting where exercise would be prescribed. However, the program was designed to be pragmatic and tailored to individual needs.

Score: [3] Equally pragmatic and explanatory

Organization:

Relevant quotes:

“An exercise physiologist supervised the delivery of the intervention but with physiotherapist input during the early stages of the programme.”

Reasoning: The intervention involved supervision from an exercise physiologist and physiotherapist, which provides more resources and expertise than may be typically available in usual care. However, it does not seem that extensive additional training or experience was required.

Score: [3] Equally pragmatic and explanatory

Flexibility - Delivery:

Relevant quotes:

“Aerobic exercise was the core exercise modality as it is accessible (i.e. includes community-based walking exercise) and does not require equipment. Participants were asked to complete short bouts (e.g. 5 × 3 minutes, with two-minute rest intervals) of low to moderate intensity aerobic exercise (e.g. stepping ergometer, cycle-ergometer, treadmill walking, rowing ergometer, arm-cranking) at 50%–69% of predicted maximum heart rate (220–age) or 12–14 on the Borg Ratings of Perceived Exertion Scale.”

“The home-exercise sessions were intended to mirror the supervised sessions in terms of intensity and duration of aerobic exercise, and also included tailored exercises for strength, flexibility and balance. Participants were encouraged to seek out opportunities to exercise in the local community (e.g. healthy living centres, health walks, fitness centres, swimming pools, etc.), based on their individual preferences.”

Reasoning: The protocol provides guidance on the exercise intensity, duration, and modalities but leaves flexibility for individually tailored programs incorporating community-based activities. This seems reasonably similar to what would be done in usual care.

Score: [4] Rather pragmatic

Flexibility - Adherence:

Relevant quotes: No discussion of measures to enforce adherence.

Reasoning: There is no indication that measures were in place to monitor or enforce adherence. Participants seemed to have flexibility similar to what would occur in usual care.

Score: [5] Very pragmatic

Follow-up:

Relevant quotes:

“Outcomes were assessed at baseline, and at three months (post-intervention) and nine months after randomisation.”

Reasoning: Outcomes were assessed at baseline, 3 months, and 9 months. There is no mention of extra visits or more extensive follow-up than would occur in usual care.

Score: [4] Rather pragmatic

Primary outcome:

Relevant quotes:

“The primary outcome was self-reported exercise behaviour at three months using the Godin Leisure Time Exercise Questionnaire (GLTEQ).”

Reasoning: The primary outcome was self-reported exercise behavior, which is a patient-centered outcome that would be relevant in usual care. The GLTEQ seems like a reasonable tool to assess this.

Score: [4] Rather pragmatic

Primary analysis:

Relevant quotes:

“All analyses were by intention to treat, whereby participants were analysed in the arm to which they were randomised irrespective of whether they complied with the intervention.”

Reasoning: An intention-to-treat analysis was used, which is consistent with a pragmatic approach.

Score: [5] Very pragmatic

Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial (2011), PragMS

Here are the PRECIS-2 scores for the trial based on the full text:

Eligibility criteria

Quotes:

“Inclusion criteria were: age of 18 years or above; BDI score of at least 14 on two consecutive occasions and no treatment from psychologist, psychotherapist or psychiatrist within the last three months.”

“Exclusion criteria were: poor English language skills or cognitive function (score of less than 24 on Mini Mental State Examination [20]); BDI score of at least 29 on two consecutive occasions; active suicidal ideas; current or life-time diagnosis of psychosis, organic mental disorder or substance dependency; Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above [21].”

The trial had strict inclusion and exclusion criteria that excluded patients based on English proficiency, cognitive impairment, suicidal ideation, psychosis, organic mental disorders, substance dependency, and high levels of disability. This reduces the similarity of trial participants to real-world patients and limits generalizability. The exclusion of patients with severe depression (BDI ≥29) also departs from real-world practice.

Score: [2] Rather explanatory

Recruitment

Quotes:

“Invitations were made between October 2008 and July 2009: face-to-face by consultants in the Sheffield Teaching Hospitals NHS Foundation Trust MS clinic (n = 288); by the Sheffield MS nurses visiting patients (n = 4); and, using ink-signed personalised letters mailed out from a neuropsychologist at Sheffield (n = 40) as well as from consultant neurologists at the Walton Centre for Neurology and Neurosurgery NHS Trust, Liverpool (n = 250).”

“Sheffield neurologists in the MS clinic, forms were completed and returned by 63 (21.8%) candidates from which we randomised 13 in 281 days (4.5% recruitment yield), or 1.4 participants per month. From the 250 recruitment packs sent out by post from The Walton Centre, forms were completed and returned by 64 (25.6%) of recipients, from which 10 participants were randomised in 149 days (4.0% recruitment yield), or two participants per month.”

The trial used multiple recruitment strategies including in-clinic recruitment and mailed letters. The overall recruitment rate was low, with only 4.1% of those invited consenting to participate. The additional effort required beyond standard clinical practice reduces pragmatism.

Score: [2] Rather explanatory

Setting

Quote:

“Invitations were made between October 2008 and July 2009: face-to-face by consultants in the Sheffield Teaching Hospitals NHS Foundation Trust MS clinic (n = 288); by the Sheffield MS nurses visiting patients (n = 4); and, using ink-signed personalised letters mailed out from a neuropsychologist at Sheffield (n = 40) as well as from consultant neurologists at the Walton Centre for Neurology and Neurosurgery NHS Trust, Liverpool (n = 250).”

The trial was conducted at two specialist NHS hospital trusts. This academic medical setting departs from the typical real-world primary care setting where depression treatment usually occurs.

Score: [2] Rather explanatory

Organisation

Quote:

“In the Sheffield region, Primary Care Trust (PCT) mental health care teams administered the CCBT, facilitating access and undertaking safety monitoring (PCTs were publicly funded organisations responsible for commissioning acute services for local populations). The CCBT service provided to trial participants was the routine service provided to all patients referred to the PCT mental health care teams.”

The CCBT intervention was delivered through existing PCT mental health care teams, reflecting usual care organization and resources.

Score: [4] Rather pragmatic

Flexibility: delivery

Quote:

“Only one out of the five participating PCTs around the Sheffield centre formally provided any kind of community facility for accessing CCBT; PCT staff warned that clients rarely used the facility and it was closed during the course of the study. Although four out of five participating PCTs were happy to arrange alternative provision for those who did not have Internet access at home, all our participants requested home use of CCBT. In the Liverpool region, a specialist neuropsychologist, based in the acute hospital facilitated access to and provided technical advice on CCBT, but did not provide additional therapeutic input.”

The CCBT intervention was delivered with flexibility, allowing home access as preferred by participants. There was no strict protocol dictating delivery.

Score: [4] Rather pragmatic

Flexibility: adherence

No relevant quotes. The paper does not mention any measures to enforce or monitor adherence. As an unguided self-administered intervention, flexibility of adherence appears high.

Score: [4] Rather pragmatic

Follow-up

Quotes:

“The completion of outcome data by postal questionnaire proved to be challenging, with multiple attempts to obtain data from many participants, particularly at later outcome assessment points.”

“Participants were contacted if they failed to keep trial appointments.”

The trial used postal questionnaires for follow-up assessment, which required significant additional effort beyond usual care. Participants were contacted if they missed appointments, also indicating more intensive follow-up.

Score: [2] Rather explanatory

Primary outcome

Quote:

“The primary clinical endpoint was the mean change in self-reported symptoms of depression as measured on the BDI. Specifically, we measured the mean change in scores between the two arms as measured at baseline, 8 and 21 weeks (13 weeks post intervention).”

The primary outcome was change in BDI score, a standard depression scale. This outcome is clinically meaningful and important to patients.

Score: [4] Rather pragmatic

Primary analysis

No relevant quotes. The paper states an intention-to-treat analysis was used but does not provide details.

Score: [NA] Not enough information

Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS (2019), PragMS

Here are the PRECIS-2 scores for the clinical trial based on the attached publication:

Eligibility criteria

Quotes:

• “Key inclusion criteria permitted the participation of men or women ≥18 years of age with confirmed and documented RRMS diagnosis (as defined by the Revised McDonald criteria)”

• “Key exclusion criteria were previous exposure to GA40, a progressive form of MS or neuromyelitis optica, the use of experimental or investigational drugs, participation in clinical drug studies within the 6 months before screening, recent use of immunosuppressive medications or immunoglobulins/monoclonal antibodies, or previous use of alemtuzumab, cladribine, cyclophosphamide, or mitoxantrone.”

The eligibility criteria are typical for an RRMS trial, excluding progressive forms of MS and severely disabled patients. The key inclusion criterion is a confirmed RRMS diagnosis. The trial excludes patients who have previously been exposed to GA40, likely to avoid bias, but does not exclude based on expected adherence or response. Overall, the criteria seem moderately pragmatic.

Score: [3]

Recruitment:

Quotes:

• “Eligible patients were randomly assigned 1:1 to receive subcutaneous injections of GA40 (n = 431) or GA20 (n = 430).”

No details are provided on how patients were recruited into the trial. However, since patients were randomized after being screened for eligibility, it seems that patients were recruited in a reasonably standard way, likely from MS clinics. There is no mention of extra efforts like media campaigns or incentives.

Score: [3]

Setting:

Quotes:

• “The CONFIDENCE study was a multinational, multicenter, randomized, parallel-group, phase 4, open-label study conducted at 88 study centers in 14 countries (Russia, Poland, Italy, France, Croatia, US [including Puerto Rico], Mexico, Spain, Austria, Turkey, Belgium, Argentina, Germany, and Finland) across different geographic regions.”

The trial was conducted across 88 centers in 14 countries across several continents. This diversity of settings indicates a pragmatic approach to increase generalizability of results.

Score: [4]

Organization:

No relevant quotes.

There are no details provided on resources, staffing, or intervention delivery. It seems the trial did not make significant changes to normal care delivery.

Score: [3]

Flexibility (delivery):

No relevant quotes.

No details are provided on how the interventions were delivered. However, since this was a trial comparing two approved dosage regimens of an existing therapy, it is likely the flexibility in delivery mirrored real-world practice.

Score: [4]

Flexibility (adherence):

Quotes:

• “Adherence to treatment when the dosing schedule differs is complicated, because missing one dose has potentially differential impacts on treatment.”

Adherence was measured through self-reported questionnaires. No measures were taken to enforce adherence. This pragmatic approach mirrors real-world practice.

Score: [4]

Follow-up:

Quotes:

• “Five scheduled visits at study sites occurred at screening (within 2 weeks prior to baseline), baseline (Month 0), and Months 1, 3, and 6 (end of the core phase).”

• “Patients also participated in self-reported, daily at-home MSQ assessments on Days 1 through 7 after the baseline visit.”

Follow-up included 5 scheduled visits over 6 months, which is reasonably frequent but not excessive. Additional patient-reported outcomes were collected daily for the first week. Follow-up intensity seems slightly greater than normal care but still moderately pragmatic.

Score: [3]

Primary outcome:

Quotes:

• “The primary endpoint was patient overall satisfaction with the medication as measured by the single-item MSQ 7-point scale (1 = extremely dissatisfied to 7 = extremely satisfied)”

The primary outcome is patient satisfaction measured by the MSQ scale. This outcome is clinically meaningful and patient-centered.

Score: [5]

Primary analysis:

Quotes:

• “The intention-to-treat (ITT) analysis set included all randomly assigned participants and were analyzed according to the treatment group to which they were randomly assigned, regardless of which treatment they actually received.”

An intention-to-treat analysis was used including all randomized patients. This pragmatic approach is appropriate for a superiority trial.

Score: [5]

Progressive resistance training did not improve walking but can improve muscle performance, quality of life and fatigue in adults with multiple sclerosis: a randomized controlled trial (2011), PragMS

Here are the PRECIS-2 scores for the trial based on the full text:

Eligibility criteria

Relevant quotes:

“Volunteers were excluded if they had an acute exacerbation of MS within 2 months of starting the program, had benign or progressive/relapsing types of MS, had a serious unstable medical condition, had any concurrent condition, for example stroke, or had participated in a PRT program in the 6 months before training started.”

“Participants were recruited through a statewide organization providing education and support to people with MS, and a large specialist MS outpatient clinic. To be included, people had to be aged 18 years or more, have a confirmed diagnosis of relapsing–remitting MS, have an Ambulation Index score of 2, 3 or 4 (mild to moderate walking disabilities), and have received medical clearance to participate.”

Reasoning: The eligibility criteria mostly match those who would receive this intervention in usual care, including adults with confirmed relapsing-remitting MS and mild to moderate walking disability. However, some exclusion criteria like recent acute exacerbation and participation in PRT in past 6 months make it slightly less pragmatic. Overall, it seems reasonably close to usual care eligibility.

Score: [4] Rather pragmatic

Recruitment

Relevant quotes:

“Recruitment information flyers were sent by mail to all potential participants registered on the mailing lists of both organizations. If interested, volunteers were asked to contact one of the researchers (KD) by telephone, during which volunteers were screened to ensure they satisfied the inclusion criteria.”

Reasoning: Recruitment was done through organizations providing education and support to people with MS, by sending flyers to their mailing lists. This seems reasonably close to how patients would be recruited or made aware of the intervention in a real-world setting. No major additional efforts like media campaigns or incentives were mentioned.

Score: [4] Rather pragmatic

Setting

Relevant quotes:

“The experimental group completed a 10-week (two times per week), PRT program in one of four community gymnasiums in metropolitan and regional areas.”

Reasoning: The setting of community gymnasiums seems very typical of where patients would receive this intervention in usual care. Multiple sites were used which further enhances pragmatism.

Score: [5] Very pragmatic

Organization

Relevant quotes:

“Each program was attended by a group of up to 12 participants, and they were supervised by up to three experienced trainers (physiotherapists and registered personal sports trainers). Each trainer directly supervised a sub-group of three or four participants.”

“The training also took the form of small group-based training; this is important because it made exercising a more social activity, and it was more cost effective and time efficient than individual training.”

Reasoning: The intervention utilized trainers with expertise typical of a real-world setting - physiotherapists and personal trainers. Resources were not substantially greater than usual care. Overall organization seems very similar to real-world implementation.

Score: [5] Very pragmatic

Flexibility of experimental intervention - delivery

Relevant quotes:

“While these were the core exercises, they could be individualized. For example, if any exercise caused discomfort, the starting position was modified or the exercise was replaced.”

Reasoning: There was flexibility in delivery of the exercises based on individual needs and tolerances. No major protocol constraints were mentioned. This matches real-world flexibility.

Score: [5] Very pragmatic

Flexibility of experimental intervention - adherence

Relevant quotes:

No relevant quotes found.

Reasoning: There is no mention of any special measures to enforce or monitor adherence. It seems to match usual encouragement.

Score: [5] Very pragmatic

Follow-up

Relevant quotes:

“Outcome measurements were taken three times: at baseline, after 10 weeks to determine the immediate effects of the intervention, and after a further 12 weeks (week 22) to determine if any benefits from the program had been sustained.”

Reasoning: Follow-up at 10 weeks and 22 weeks seems reasonably typical to assess sustainability of outcomes. No mentions of more extensive unscheduled visits or data collection.

Score: [4] Rather pragmatic

Primary outcome

Relevant quotes:

“Changes in walking endurance were measured with the 2-minute walk test (2MWT).”

“Changes in maximal walking speed were measured by recording the time taken to walk the middle 10 m of a level 14-m walkway using a stopwatch.”

Reasoning: The primary outcomes of walking endurance and speed are highly relevant for MS patients and measure skills needed in daily life. They do not require special expertise to assess.

Score: [5] Very pragmatic

Primary analysis

Relevant quotes:

“Intention-to-treat analysis was applied, with all participants who were allocated and commenced their program included in analysis. Where data were missing, the carry forward technique was used.”

Reasoning: An intention-to-treat analysis was used including all randomized participants. This is very typical of real-world implementation.

Score: [5] Very pragmatic

Effects of an individual 12-week community-located “start-to-run” program on physical capacity, walking, fatigue, cognitive function, brain volumes, and structures in persons with multiple sclerosis (2019), PragMS

Here are the PRECIS-2 scores for the trial described in the paper “Effects of an individual 12-week community-located “start-to-run” program on physical capacity, walking, fatigue, cognitive function, brain volumes, and structures in persons with multiple sclerosis”:

Eligibility criteria:

Quotes:

“Adults with MS were recruited through announcements at REVAL rehabilitation research institute (UHasselt), Flemish MS rehabilitation centers and MS Society, and Move-to-Sport. Adults diagnosed with MS were included based on the ability to walk 5 km without rest or use of assistive device.”

“Interested pwMS attended an information session and jointly walked 5 km for verification of their ability.”

“Exclusion criteria were reports to have run 5 km in the preceding 6 months or a relapse occurring in the preceding 3 months.”

Reasoning: The eligibility criteria are fairly broad, including adults with MS who are able to walk 5km without assistance. The main exclusions are related to recent running activity and relapses, to avoid carryover effects. Overall, the criteria seem reasonably similar to MS patients who might undertake such a running program in usual care.

Score: [4]

Recruitment:

Quotes:

“Adults with MS were recruited through announcements at REVAL rehabilitation research institute (UHasselt), Flemish MS rehabilitation centers and MS Society, and Move-to-Sport.”

“Interested pwMS attended an information session and jointly walked 5 km for verification of their ability.”

Reasoning: Recruitment was done through rehabilitation centers, MS societies, and word of mouth. While this involves some effort beyond usual care, it seems reasonably similar to how patients might learn about and enroll in a community running program in real life. No excessive advertising or incentives noted.

Score: [4]

Setting:

Quotes:

“Participants were asked to weekly upload data to allow remote supervision of the training adherence by the research assistant. If a participant had been inactive, a phone call was made for enquiry. Besides, two group training sessions were organized (weeks 4 and 8) at a 400-m outdoor running track at KULeuven.”

Reasoning: The setting was a community-based running program with occasional supervised sessions at a university track. This pragmatic setting matches real-world conditions where the training would be applied after the trial.

Score: [5]

Organization:

Quotes:

“Participants in the training group adhered well to the remotely supervised program while showing low adverse event rates.”

“pwMS received training instructions by email. They were asked to train three times weekly according to a personalized training intensity schedule that was based on their baseline aerobic capacity.”

Reasoning: The intervention utilized remote supervision by email and activity trackers. No special staffing or resources beyond what would be available in usual care are described.

Score: [5]

Flexibility: delivery

Quotes:

“An illustration of a training protocol is provided in supplementary material S1.”

“During the first weeks, training consisted of longer walking bouts, interspersed with short 1′ running bouts. The relative amount of running gradually increased until participants were able to run 5 km without interruption at 12 weeks.”

Reasoning: The running program followed a standardized gradual progression protocol. While not highly flexible, some tailoring to each participant’s baseline fitness was allowed. Overall, moderately pragmatic.

Score: [3]

Flexibility: adherence

Quotes:

“Participants who completed the training program showed high adherence. The EXP group completed 607 of 648 prescribed sessions (94%).”

Reasoning: No special efforts to enforce adherence are described. Participants received encouragement but were free to follow program at own pace.

Score: [5]

Follow-up:

Quotes:

“Evaluation was performed at two time points (0 and 12 weeks).”

Reasoning: Follow-up matches expected duration of the 12-week program, with pre/post analysis. Does not exceed standard care.

Score: [5]

Primary outcome:

Quotes:

“The primary outcome measures were physical fitness, walking capacity and perceived ability, functional mobility, and quality of life.”

Reasoning: The outcomes of fitness, walking ability, mobility, and quality of life are highly relevant for MS patients undertaking a running program.

Score: [5]

Primary analysis:

Quotes:

“Intention-to-treat analysis was performed.”

Reasoning: An intention-to-treat analysis was used, implying all randomized participants were included. This pragmatic approach mirrors real-world conditions.

Score: [5]

Investigating the potential disease-modifying and neuroprotective efficacy of exercise therapy early in the disease course of multiple sclerosis: The Early Multiple Sclerosis Exercise Study (EMSES) (2022), PragMS

Here are the PRECIS-2 domain scores for the clinical trial described in the paper “Investigating the potential disease-modifying and neuroprotective efficacy of exercise therapy early in the disease course of multiple sclerosis: The Early Multiple Sclerosis Exercise Study (EMSES)” (1568.pdf):

Eligibility criteria:

Quote: “Patients (n = 84) were recruited in collaboration with six Danish regional MS clinics and The Danish MS Society. Inclusion criteria were (1) 18–60 years of age, (2) ⩽2 years since clinical diagnosis with relapsing remitting MS (RRMS) and (3) no relapses or changes in medication status 8 weeks prior to inclusion.”

Reasoning: The eligibility criteria are fairly broad, including adult RRMS patients within 2 years of diagnosis. The only major exclusions are recent relapse and medication changes. This matches typical eligibility for early RRMS patients in usual care.

Score: [4]

Recruitment:

Quote: “Patients were randomized to the two study conditions by the sealed envelope principle in a 1:1 ratio stratified by line of treatment.”

Reasoning: Patients were recruited through Danish MS clinics, reflecting recruitment through usual healthcare settings. No extra effort beyond normal clinic recruitment is described.

Score: [5]

Setting:

Quote: “The present study is a national multicentre single-blinded parallel group randomized controlled trial (RCT) comparing two groups receiving either supervised exercise therapy (intervention group) or health education (active control group).”

Reasoning: The multicenter design across regional Danish MS clinics represents the typical real-world settings where patients receive care.

Score: [5]

Organization:

Quote: “The supervised exercise sessions were performed twice weekly for the full study period of 48 weeks, and was planned on the basis of four principles…Therefore, the exercise intervention was planned as high-intense aerobic exercise, monitored relative to the patients’ individual maximal heart rate (HRmax), and progressed within and between 4 meso cycles of 12 weeks.”

Reasoning: The exercise intervention required specialized equipment, training and monitoring beyond usual care. This differed from typical organization.

Score: [2]

Flexibility (delivery):

Quote: “In addition to usual care the control group of this study received four 1.5-hour health educational sessions throughout the study periods of 48 weeks.”

Reasoning: Health education sessions were provided to the control group as usual care. The intervention group received a standardized exercise protocol. This contrasts with flexibility in usual care.

Score: [2]

Flexibility (adherence):

Quote: “Patients in the supervised exercise group completed 90.0 (8.6)% of the planned sessions at an average intensity of 84.4 (3.0)% HRmax.”

Reasoning: Adherence was measured but patients were not excluded for non-adherence. Encouragement to adhere to the protocol was similar to encouragement in usual care.

Score: [4]

Follow-up:

Quote: “All patients were scanned using the exact same 3-Tesla MRI scanner (MAGNETOM Skyra, Siemens Medical Systems, Erlangen, Germany) at the same location, for all patients, and at all timepoints.”

Reasoning: Follow-up schedule matched the study timepoints with MRI scans. This intensity is greater than typical follow-up in usual care.

Score: [2]

Primary outcome:

Quote: “The relapse rate and the global brain atrophy rate were the primary outcomes of this study.”

Reasoning: Relapse rate and brain atrophy are clinically meaningful outcomes to patients.

Score: [5]

Primary analysis:

Quote: No explicit description of primary analysis method.

Reasoning: The analysis method is not described, so it cannot be determined if it was by intention-to-treat.

Score: [NA]

Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial (2014), PragMS

Here are the PRECIS-2 scores with explanations for the trial “Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial” based on the provided briefings and full text:

Eligibility criteria:

Relevant quotes:

“Men and women aged 18–65 years with relapsing forms of MS, as defined by the 2005 revised McDonald criteria [14], and an Expanded Disability Status Scale (EDSS) score of 0–5.5 were eligible to participate in the study.”

“Patients were required to have received a single iDMT (except natalizumab) continuously for at least 6 months prior to study initiation and to be candidates for therapy change.”

“Patients were required to have been naïve to fingolimod treatment.”

Explanation: The eligibility criteria are reasonably broad, including adult patients with relapsing forms of MS up to EDSS 5.5 who have been on a single iDMT for at least 6 months. The main exclusions are safety-related such as cardiac conditions. Overall, the criteria reflect typical patients who would receive DMTs in usual care.

Score: [4] Rather pragmatic

Recruitment:

Relevant quotes:

No details provided on how patients were recruited.

Explanation: No information is provided on how patients were recruited.

Score: [NA]

Setting:

Relevant quotes:

“EPOC was a 6-month, randomized, open-label, multicenter, phase 4 study conducted in the USA and Canada.”

Explanation: The study was conducted across multiple centers in the USA and Canada. No further details are provided on the settings.

Score: [3] Equally pragmatic and explanatory

Organization:

Relevant quotes:

No details provided on expertise or resources required to deliver the intervention.

Explanation: No information is provided on the organization of care delivery.

Score: [NA]

Flexibility of Experimental Intervention - Delivery:

Relevant quotes:

No details provided on flexibility in delivering fingolimod.

Explanation: No information is provided on flexibility in how fingolimod was delivered to patients.

Score: [NA]

Flexibility of Experimental Intervention - Adherence:

Relevant quotes:

No details provided on measures to enforce adherence.

Explanation: No information is provided on measures to ensure adherence to fingolimod.

Score: [NA]

Follow-up:

Relevant quotes:

“All outcomes were evaluated after 6 months of treatment.”

Explanation: Patients were followed for 6 months to assess outcomes. No details are provided on frequency or intensity of follow-up.

Score: [3] Equally pragmatic and explanatory

Primary Outcome:

Relevant quotes:

“The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score from baseline to 6 months [15].”

“This was measured using the Global Satisfaction subscale score on the TSQM v1.4, where higher scores indicate greater satisfaction.”

Explanation: The primary outcome is patient satisfaction with treatment measured by the TSQM questionnaire. This outcome is directly relevant and meaningful to patients.

Score: [5] Very pragmatic

Primary Analysis:

Relevant quotes:

No details provided on handling of non-adherence or missing data.

Explanation: No information is provided on the primary analysis methods.

Score: [NA]

User prompt

You are an expert in clinical trial design and are tasked to assess the PRECIS-2 scores of a trial based on the full text of its publication. You have the briefing in the attached "Loudon 2015.pdf" and "PRECIS Toolkit.pdf"

The full text to be assessed is attached as "ID.pdf".

For each of the 9 domains of PRECIS-2, perform the following steps:

1. Extract 1-3 relevant quotes from the full text.

2. Explain your reasoning in 1 paragraph.

3. Give a score X from 1 (very explanatory) to 5 (very pragmatic) in square brackets like this: "Score: [X]". If the full text does not contain enough information to assess a specific domain, report "Score: [NA]".

Do not provide a final summary paragraph in the end.